VasCure for Vascular Repair CMCV-013-609Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00859389005140), received between Sep 4, 2015 and Jan 15, 2025 — classified as 26 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A REPORT WAS RECEIVED FROM ELUTIA'S BUSINESS PARTNER ON 17-DECEMBER-2024, OF TWO (2) ADVERSE EVENTS RELATED TO PATIENTS HAVING BEEN IMPLANTED WITH VASCURE FOR VASCULAR REPAIR PATCH (1CM X 10CM) DEVELOPING ANEURYSMS AFTER IMPLANT. THE REPORTED EVENTS WILL BE FILED IN 2 DIFFERENT ADVERSE EVENT REPORTS SPECIFIC TO THE PATIENT AND REPORTED ELUTIA PRODUCT INFORMATION. THE INITIAL EVENT, THE SUBJECT OF THIS REPORT, USED A 1CM X 10CM SIZE VASCURE FOR VASCULAR REPAIR PATCH (MODEL # CMCV-013-609, LOT M24F1186 WAS USED TO TREAT PATIENT #1. THE SECOND EVENT (PATIENT #2) WILL BE ADDRESSED IN MDR 3005619880-2025-00002. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE IMPLANTING PHYSICIAN WITH NO FURTHER INFORMATION HAVING BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Aneurysm

  MAUDE report 21163856 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A REPORT WAS RECEIVED FROM ELUTIA'S BUSINESS PARTNER ON 17-DECEMBER-2024 OF TWO (2) ADVERSE EVENTS RELATED TO PATIENTS HAVING BEEN IMPLANTED WITH VASCURE FOR VASCULAR REPAIR PATCH (1CM X 10CM) DEVELOPING ANEURYSMS AFTER IMPLANT. THE REPORTED EVENTS WILL BE FILED IN 2 DIFFERENT ADVERSE EVENT REPORTS SPECIFIC TO THE PATIENT AND REPORTED ELUTIA PRODUCT INFORMATION. A 1CM X 10CM SIZE VASCURE FOR VASCULAR REPAIR PATCH (MODEL # CMCV-013-609, LOT M24D1113) WAS USED TO TREAT PATIENT #2 AND IS THE SUBJECT OF THIS REPORT. THE SECOND EVENT (PATIENT #2) WILL BE ADDRESSED IN. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE IMPLANTING PHYSICIAN WITH NO FURTHER INFORMATION HAVING BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Aneurysm

  MAUDE report 21163855 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  EMAIL FROM BUSINESS PARTNER WITH AN ADVERSE EVENT REPORT FILED BY THEIR SALES REPRESENTATIVE. INCIDENT REPORT, DATED (B)(6) 2023, LISTS SIX (6) OCCURRENCES OF INFECTION OF FEMORAL ENDARTERECTOMIES OVER THE PAST 9 MONTHS FOLLOWING REPAIR USING THE VASCURE FOR VASCULAR REPAIR DEVICE (MODEL #: UNKNOWN, LOT #: UNKNOWN) AND NO SPECIFIED IMPLANT DATE(S). THE REPORT FROM THE SALES REPRESENTATIVE STATES "THEY DON'T KNOW IF IT WAS DUE TO THE PATCH; THEY TYPICALLY WOULD SEE 1-2 INFECTIONS OVER A YEAR." ALL PATIENTS WERE REPORTED AS HAVING "NO INFECTIONS PRESENT AT THE TIME OF INITIAL SURGERY". PATIENTS REPORTED TO HAVE DEVELOPED THE INFECTIONS BETWEEN 2-6 WEEKS POST-OPERATIVELY. ALL PATIENTS REPORTED NOW AS DOING WELL; NO DEATHS REPORTED. THE REPORTED 6 EVENTS WILL BE FILED IN 3 DIFFERENT ADVERSE EVENT REPORTS SPECIFIC TO THE PATIENT AND HEALTH EVENT CODES ASSOCIATED WITH EACH EVENT - SPECIFICALLY MDR 3005619880-2023-00005, (PATIENT 1), MDR 3005619880-2023-00006 (PATIENT 2), AND MDR 3005619880-2023-00007 (PATIENTS 3 - 6 [THIS REPORT]). THIS REPORT IS ASSOCIATED WITH PATIENTS #3 - #6 COVERING THE FOUR PATIENTS WITH REPORTED POST-OP INFECTIONS. REP REPORTED THAT "THE SURGEON TOLD ME THAT THERE

  Patient problems: Unspecified Infection

  MAUDE report 18145224 ↗
• InjuryNov 15, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Material Rupture; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  EMAIL FROM BUSINESS PARTNER WITH AN ADVERSE EVENT REPORT FILED BY THEIR SALES REPRESENTATIVE. INCIDENT REPORT, DATED ON (B)(6) 2023, LISTS SIX (6) OCCURRENCES OF INFECTION OF FEMORAL ENDARTERECTOMIES OVER THE PAST 9 MONTHS FOLLOWING REPAIR USING THE VASCURE FOR VASCULAR. REPAIR DEVICE (MODEL #: UNKNOWN, LOT #: UNKNOWN) AND NO SPECIFIED IMPLANT DATE(S). THE REPORT FROM THE SALES REPRESENTATIVE STATES "THEY DON'T KNOW IF IT WAS DUE TO THE PATCH; THEY TYPICALLY WOULD SEE 1-2 INFECTIONS OVER A YEAR." ALL PATIENTS WERE REPORTED AS HAVING "NO INFECTIONS PRESENT AT THE TIME OF INITIAL SURGERY". PATIENTS REPORTED TO HAVE DEVELOPED THE INFECTIONS BETWEEN 2-6 WEEKS POST-OPERATIVELY. ALL PATIENTS REPORTED NOW AS DOING WELL; NO DEATHS REPORTED. THE REPORTED 6 EVENTS WILL BE FILED IN 3 DIFFERENT ADVERSE EVENT REPORTS SPECIFIC TO THE PATIENT AND HEALTH EVENT CODES ASSOCIATED WITH EACH EVENT - SPECIFICALLY MDR 3005619880-2023-00005, (PATIENT 1), MDR (PATIENT 2 [THIS REPORT]), AND MDR 3005619880-2023-00007 (PATIENTS 3 - 6). THIS MDR IS OPENED FOR PATIENT #2. THIS PATIENT WAS REPORTED TO HAVE A "BLOWOUT" DUE TO SUTURE LINE BLEEDING. THIS PATIENT ALSO REPORTEDLY DEVELOPED AN INFECTION. THE EVENT WAS

  Patient problems: Rupture; Unspecified Infection

  MAUDE report 18145217 ↗
• InjuryNov 15, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Material Rupture; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  EMAIL FROM BUSINESS PARTNER WITH AN ADVERSE EVENT REPORT FILED BY THEIR SALES REPRESENTATIVE. INCIDENT REPORT, DATED ON (B)(6) 2023, LISTS SIX (6) OCCURRENCES OF INFECTION OF FEMORAL ENDARTERECTOMIES OVER THE PAST 9 MONTHS FOLLOWING REPAIR USING THE VASCURE FOR VASCULAR. REPAIR DEVICE (MODEL #: UNKNOWN, LOT #: UNKNOWN) AND NO SPECIFIED IMPLANT DATE(S). THE REPORT FROM THE SALES REPRESENTATIVE STATES "THEY DON'T KNOW IF IT WAS DUE TO THE PATCH; THEY TYPICALLY WOULD SEE 1-2 INFECTIONS OVER A YEAR." ALL PATIENTS WERE REPORTED AS HAVING "NO INFECTIONS PRESENT AT THE TIME OF INITIAL SURGERY". PATIENTS REPORTED TO HAVE DEVELOPED THE INFECTIONS BETWEEN 2-6 WEEKS POST-OPERATIVELY. ALL PATIENTS REPORTED NOW AS DOING WELL; NO DEATHS REPORTED. THE REPORTED 6 EVENTS WILL BE FILED IN 3 DIFFERENT ADVERSE EVENT REPORTS SPECIFIC TO THE PATIENT AND HEALTH EVENT CODES ASSOCIATED WITH EACH EVENT - SPECIFICALLY MDR (PATIENT 1 [THIS REPORT]), MDR 3005619880-2023-00006 (PATIENT 2), AND MDR 3005619880-2023-00007 (PATIENTS 3 - 6). THIS REPORT IS ASSOCIATED WITH PATIENT #1 WHO WAS REPORTED TO HAVE A "BLOWOUT" WITH A HOLE IN THE PATCH. THIS PATIENT ALSO REPORTEDLY DEVELOPED AN INFECTION. THE EVENT WAS RESOL

  Patient problems: Rupture; Unspecified Infection

  MAUDE report 18145216 ↗
• InjuryNov 15, 2023Material Rupture; Material Rupture

  REPORT FROM BUSINESS PARTNER REGARDING ADVERSE EVENT DESCRIBED AS "PATCH BLEW OUT 5 WEEKS AFTER A CAROTID ENDARTERECTOMY." PATIENT HAD BEEN IMPLANTED WITH VASCURE FOR VASCULAR REPAIR (MODEL # CMCV-014-609, LOT #UNKNOWN). EVENT FAILURE REPORTED AS DEVICE-RELATED LARGE HEMATOMA REQUIRING REPAIR BY CAROTID BYPASS. DATE REPORT RECEIVED BY PARTNER 10OCT2023, AND FORWARDED TO AZIYO/ELUTIA ON 11OCT2023 - ACTUAL DATE OF EVENT NOT KNOWN. NO FURTHER INFORMATION IS AVAILABLE, A FOLLOW-UP REPORT WILL BE UPDATED IF MORE INFORMATION IS RECEIVED REGARDING THIS EVENT.

  Patient problems: Hematoma; Rupture

  MAUDE report 18144317 ↗
• InjuryNov 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  EMAIL RECEIVED FROM SALES REP: "PATIENT PRESENTED 10 YEARS AFTER INITIAL SURGERY [FOR CAROTID REPAIR WITH VASCURE] WITH ASYMPTOMATIC PSEUDOANEURYSM 2.5CM. DURING A MODIFIED TCAR (TRANSCAROTID ARTERY REVASCULARIZATION) PROCEDURE, A STENT WAS PLACED THROUGH A CATHETER; VASCURE PATCH WAS NOT REMOVED." PSEUDOANEURYSM DESCRIBED AS ON THE EDGE OF PATCH AND NOT IN THE MIDDLE. PHYSICIAN STATED THAT HE WAS NOT SURE IT HAD ANYTHING TO DO WITH AZIYO PATCH BUT CONSIDERED THIS "ATYPICAL" AND "CONSISTENT WITH LONG TERM PATCH DATA THAT PATCHES CAN BECOME ANEURYSMIC". PATIENT HAD NO REPORTED COMORBIDITIES AND IS DOING WELL.

  Patient problems: Pseudoaneurysm

  MAUDE report 15714373 ↗
• InjuryMay 5, 2022Peeled/Delaminated; Peeled/Delaminated

  AZIYO SALES REP REPORTED THAT PHYSICIAN PLACED AN AZIYO VASCURE FOR VASCULAR REPAIR DEVICE (MODEL CMCV-013-609, LOT M21K1359) TO REPAIR A CAROTID ARTERY. PHYSICIAN REPORTED "PATCH FAILED WITHIN THE SUTURE LINE". HE STATED THAT THE PATCH APPEARED TO "DELAMINATE IN THE CENTER OF THE PATCH". DATE OF IMPLANT REPORTED AS (B)(6) 2022. ON (B)(6)2022, PATIENT HAD A PLACEMENT OF A HEPARIN-BOND COVERED STENT AND (B)(6) 2022 HAD THE DRAINAGE OF A HEMATOMA. THE AZIYO DEVICE REMAINS IN PLACE.

  Patient problems: Failure of Implant; Hematoma

  MAUDE report 14285962 ↗
• InjuryJun 1, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO AN AZIYO BIOLOGICS' SALES REPRESENTATIVE VIA EMAIL THAT SURGEON USED A AZIYO VASCURE FOR VASCULAR REPAIR (MODEL #CMCV-014-609, LOT # M20F1174) FOR A DE NOVO CAROTID ENDARTERECTOMY ON (B)(6) 2020. ON ROUTINE POST-OP ULTRASOUND, PSEUDOANEURYSM WAS FOUND IN PATCH. ON (B)(6) 2020, THE PATCH WAS REMOVED AND REPLACED DUE TO A PSEUDOANEURYSM IN THE MIDDLE OF THE PATCH. THE PATIENT IS DOING WELL WITH THE NEW PATCH. THIS ISSUE WAS REPORTED TO AZIYO BIOLOGICS ON 5/05/2021, ON 5/11/2021 ADDITIONAL INFORMATION RECEIVED FROM HOSPITAL PATHOLOGY STATING DIAGNOSIS AS RIGHT CAROTID PSEUDOANEURYSM, EXCISION REPAIR: ARTERIAL WALL TISSUE WITH MIXED INFLAMMATION AND MURAL DEGENERATIVE CHANGES CONSISTENT WITH STATED ORIGIN.

  Patient problems: Pseudoaneurysm

  MAUDE report 11912522 ↗
• InjuryDec 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED BY AN AZIYO SALES REPRESENTATIVE ON (B)(6) 2020 THAT A 1CM X 10CM VASCURE FOR VASCULAR REPAIR (MODEL #: CMCV-014-609, LOT #: M20G1210) WAS USED IN A CAROTID ENDARTERECTOMY PROCEDURE ON A MALE PATIENT ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT PRESENTED WITH A HEMATOMA COVERING HIS RIGHT NECK. THE PATIENT WAS TRANSFERRED TO BAPTIST HEALTH, WHERE THE ORIGINAL IMPLANTING SURGEON ELECTED TO RE-OPEN THE SITE. UPON ACCESSING THE CAROTID ARTERY, THE SURGEON REPORTED THAT THE INTEGRITY OF THE PATCH APPEARED TO BE COMPROMISED, REPORTING THAT THE ECM PATCH APPEARED TO HAVE DISINTEGRATED. IT WAS ALSO NOTED THAT THE IMPLANTING SURGEON RECALLED THE PATCH IN QUESTION BEING DIFFICULT TO PENETRATE WHILE SUTURING DURING THE ORIGINAL PROCEDURE. THE VASCURE PATCH WAS EXPLANTED AND REPLACED WITH BOVINE PERICARDIUM. PATIENT IS DOING WELL.

  Patient problems: Hematoma

  MAUDE report 11051758 ↗
• InjuryNov 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED ON 10/05/2020 BY AN AZIYO SALES REPRESENTATIVE THAT THEY WERE NOTIFIED OF AN ADVERSE EVENT RELATED TO AN IMPLANT OF AN AZIYO VASCURE FOR VASCULAR REPAIR (MODEL #: CMCV-013-609; LOT #: UNKNOWN) PERFORMED IN (B)(6) 2019 (EXACT DATE NOT REPORTED - (B)(6) USED FOR DATE OF IMPLANT FIELD) USED IN CAROTID ENDARTERECTOMY. ON (B)(6) 2020 THE PATIENT RETURNED WITH A SUSPECTED PSEUDOANEURYSM AND UNDERWENT A PROCEDURE TO REMOVE REPAIR. THE SURGEON REPORTED THAT THEY FOUND A BLOW OUT AT THE BASE OF THE PATCH AND A SAMPLE WAS SENT TO PATHOLOGY. ADDITIONAL FOLLOW-UPS WITH PHYSICIAN AND SALES REPRESENTATIVE PROVIDED NO FURTHER INFORMATION ON THE REPORTED EVENT.

  Patient problems: Pseudoaneurysm

  MAUDE report 10784410 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON 09/24/2020 BY A AZIYO SALES REPRESENTATIVE THAT THEY SPOKE WITH PHYSICIAN THIS MORNING REGARDING AN ADVERSE EVENT RELATED TO AN IMPLANT OF A AZIYO VASCURE (MODEL #: CMCV-014-609; LOT #: M20D1145) PERFORMED ON (B)(6) 2020 FOR A CAROTID ENDARTERECTOMY ON A RELATIVELY YOUNG AND OTHERWISE HEALTHY PATIENT. THE PATIENT RETURNED THIS WEEK WITH A HEMATOMA AND WAS REOPERATED ON THIS MORNING. THE PATCH WAS FOUND TO HAVE DISINTEGRATED AT THE CORNER FOR NO APPARENT REASON. A SAMPLE WAS SENT FOR TO THE HOSPITAL PATHOLOGY LAB FOR HISTOLOGY. UPON EXPOSURE DURING RE-OP, THE PHYSICIAN OBSERVED THAT THE VASCURE PATCH HAD DEHISCED IN THE CENTER, WITH ORIGINAL SUTURES LEFT INTACT ANCHORING THE PATCH TO THE ARTERY. FURTHER INFORMATION RECEIVED FROM PHYSICIAN INDICATING THAT THE HOSPITAL LAB SAMPLE WAS FOUND TO HAVE BEEN INFECTED WITH KLEBSIELLA.

  Patient problems: Hematoma

  MAUDE report 10736414 ↗
• InjuryDec 3, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT A CAROTID ENDARTERECTOMY WAS PERFORMED ON (B)(6) 2019. THE VASCURE WAS SOAKED FOR LESS THAN ONE MINUTE IN SALINE AND WAS SEWN TO PATIENT TISSUE. THE PATIENT REQUIRED SURGICAL INTERVENTION AND WAS RE-OPERATED ON (B)(6) 2019 TO RESOLVE WHAT WAS DESCRIBED AS A "BLOW OUT OF THE AZIYO CAROTID PATCH". THE PROBABLE CAUSE OF THE EVENT PER THE PHYSICIAN WAS INFECTION; THE PATIENT TESTED POSITIVE FOR GRAM NEGATIVE INFECTION (STAPH SCHLEIFERI AND STAPH HOMINIS). THE VASCURE PRODUCT WAS EXPLANTED AND REPLACED WITH A BOVINE PATCH.

  Patient problems: Unspecified Infection

  MAUDE report 9404964 ↗
• InjuryNov 14, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT A CAROTID ENDARTERECTOMY WAS PERFORMED ON A MALE PATIENT ON (B)(6) 2019. THE VASCURE WAS SOAKED FOR LESS THAN ONE MINUTE IN SALINE AND WAS SEWN WITH A 6-0 PROLENE TO THE PATIENT'S TISSUE. IT WAS STATED THAT "PATIENT DISCHARGED HOME (B)(6) 2019 HAD DISCOMFORT IN NECK WITH HEMATOMA, RE-ADMITTED (B)(6) 2019. TAKEN TO SURGERY WHERE ECM PATCH HAD "SLOUGHED" AWAY WHERE SUTURE WOULDN'T HOLD TO VASCURE. RE-OPERATION WHERE VEIN PATCH WAS SEWN INTO PLACE AFTER ECM WAS EXPLANTED. PATIENT RETURNED TO OPERATING ROOM WHERE VEIN PATCH WAS EXPLANTED AND A DACRON PATCH WAS SEWN IN TO REPLACE." IT CAN BE NOTED THAT THE PATIENT HAD UNCONTROLLED HYPERTENSION. PROBABLE CAUSE OF THE EVENT WAS STATED AS "UNSURE". THE PATIENT WAS DISCHARGED ON (B)(6) 2019 AND IS RECOVERING AT HOME.

  Patient problems: Hematoma

  MAUDE report 9321242 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ADMITTED TO THE OR FOR A RE-DO ON AN INFECTED ENDARTERECTOMY. BOVINE PATCH WAS EXPLANTED AND REPLACED USING AZIYO VASCURE ON (B)(6) 2019. BOTH THE BOVINE PATCH, FEMORAL ARTERY, BYPASS GRAPH AND SURROUNDING TISSUE OF THE GROIN WERE BADLY INFECTED. IT WAS REPORTED THAT ON (B)(6) 2019 THE VASCURE PATCH HAD DISINTEGRATED/DISSOLVED, FEMORAL ARTERY HAD THROMBOSED AND INFECTION WAS PRESENT. SERRATIA MARCESCENS WAS THE CONFIRMED PATHOGEN. THE SERRATIA MARCESCENS PATHOGEN HAS BEEN PRESENT MULTIPLE TIMES (THE PATIENT WAS GROWING IT WHEN THE VASCURE WAS IMPLANTED) WITH THIS PATIENT AND THE PATIENT'S PREVIOUS HISTORY. THE PHYSICIAN WAS NOT SURE IF THE VASCURE PATCH WAS SEWN TO VIABLE TISSUE AND THAT THIS COULD HAVE CONTRIBUTED TO THE ADVERSE EVENT. THE PATIENT WAS REPORTED AS STABLE AND HEALING.

  Patient problems: Thrombus; Unspecified Infection

  MAUDE report 9315072 ↗
• InjuryAug 19, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A CAROTID ENDARTERECTOMY THE ECM FOR VASCULAR REPAIR WAS USED IN THE CAROTID ARTERY ON (B)(6) 2015. THE PATIENT WAS A (B)(6) YEAR-OLD MALE WITH NO LISTED COMORBIDITIES. THE ECM WAS SOAKED FOR LESS THAN 1 MINUTE IN SALINE AND WAS SECURED TO THE PATIENT'S TISSUE WITH A 6-0 PROLENE SUTURE. ON (B)(6) 2019 THERE WAS A LARGE PSEUDOANEURYSM OF PATCH WITH THROMBOSIS AND STROKE (EMBOLIC) SYMPTOMS. AS OF (B)(6) 2019 THE TREATMENT OF THE PATIENT IS TO BE DETERMINED BUT LISTED POSSIBLE INTRAVASCULAR STENT. THE DOCTOR STATES THAT THE EVENT IS "DEFINITELY RELATED" TO THE DEVICE.

  Patient problems: Pseudoaneurysm; Thrombosis

  MAUDE report 8908117 ↗
• InjuryMay 8, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT A VASCURE FOR VASCULAR REPAIR (MODEL CMCV-014-609, LOT M19A1044) WAS IMPLANTED FOR A CAROTID ENDARTERECTOMY (CEA) PROCEDURE ON (B)(6) 2019 IN A (B)(6) MALE PATIENT. THE DEVICE WAS SOAKED FOR ONE MINUTE IN SALINE. THE DEVICE WAS SUTURED TO CAROTID ARTERY WITH A 7-0 PROLENE SUTURE. NO ADHESIVE AGENTS WERE USED. AFTER IMPLANTING THE PRODUCT ALONG THE CAROTID ARTERY, SURGEON SAYS IT DID NOT LOOK NORMAL AND WAS CONCERNED THAT PRODUCT SEPARATION HAD OCCURRED. THE PRODUCT WAS EXPLANTED ((B)(6) 2019) AFTER THE SURGEON WAS ABLE TO CONFIRM ON ULTRASOUND THAT SEPARATION HAD OCCURRED. A DIFFERENT PRODUCT WAS THEN USED FOR THE PROCEDURE. THE SITE STATES THAT THE EVENT IS NOT RELATED TO THE PROCEDURE AND NOT RELATED TO THE DEVICE AND NO PATIENT COMORBIDITIES. NO CONCERNS WITH PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8593042 ↗
• InjuryApr 25, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT A VASCULAR ECM (FP-20437-09, CMCV-014-609, 1CM X 10CM) WAS IMPLANTED FOR A CAROTID ENDARTERECTOMY (CEA) ON (B)(6) 2018 IN A MALE PATIENT. THE DEVICE WAS SOAKED FOR 30 SECONDS IN SALINE. STANDARD PROCEDURE GUIDELINES WERE FOLLOWED. THE ECM WAS SUTURED TO PATIENT TISSUE WITH A PROLENE SUTURE. NO ADHESIVE AGENTS WERE USED; MAY HAVE USED THROMBIN. SYMPTOMS OCCURRED AROUND 3-MONTH CHECKUP. NOTICEABLE BULGE AT WOUND SITE. ULTRASOUND CONFIRMED CAROTID ANEURYSM. PICTURES DURING EXCISION ON (B)(6) 2019 SHOW LARGE, BALLOONED ANEURYSM IN THE PATCH. THE ECM PATCH ANEURYSM WAS COMPLETELY EXCISED AND REPLACED WITH AN AUTOLOGOUS VEIN PATCH. THE SITE STATES THAT THE EVENT IS POSSIBLY RELATED TO THE PROCEDURE AND PROBABLY RELATED TO THE DEVICE. PATIENT IS REPORTED AS DOING WELL.

  Patient problems: Aneurysm

  MAUDE report 8551247 ↗
• MalfunctionNov 6, 2018Peeled/Delaminated; Peeled/Delaminated

  ON (B)(6) 2018 IT WAS REPORTED THAT AN ECM FOR VASCULAR REPAIR DEVICE WAS IMPLANTED ON A FEMALE PATIENT DURING A COMMON FEMORAL ENDARTERECTOMY. THE ECM WAS SOAKED IN SALINE FOR 1 MINUTE AND 24 SECONDS, THEN PLACED ON WET LAP FOR APPROXIMATELY 5-7 MINUTES. AFTER THE CASE WAS COMPLETE, THE PHYSICIAN INFORMED THE AZIYO TECHNICAL SALES REPRESENTATIVE THAT WHILE THE ECM WORKED GREAT, A CORNER OF THE PRODUCT HAD DELAMINATED. THE PHYSICIAN STATED THAT HE HAD SEWN THROUGH ALL OF THE ECM LAYERS AND PUT AN EXTRA STITCH IN THE CORNER. THE ECM WAS SUTURED TO THE PATIENT'S TISSUE AND NO ADHESIVE AGENTS WERE USED. THE PHYSICIAN ALSO WAITED EXTRA TIME TO MAKE SURE THERE WAS NO BLEEDING AT THE CORNER OF THE PRODUCT. THE PHYSICIAN SAID HE WAS NOT CONCERNED ABOUT THE PERFORMANCE OF THE ECM. ACCORDING TO THE PHYSICIAN, THE EVENT WAS NOT RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE ECM DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8041697 ↗
• InjurySep 4, 2018Material Rupture; Material Rupture

  ON 8/6/2018, AZIYO RECEIVED A REPORT OF AN INCIDENT ASSOCIATED WITH USE OF ECM FOR VASCULAR REPAIR (ADDITIONAL DETAILS WERE PROVIDED ON 8/15/2018). THE PATIENT IS A (B)(6) FEMALE WHO UNDERWENT CAROTID ENDARTERECTOMY REPAIR ON (B)(6) 2018 USING A 1 X 10 CM ECM FOR VASCULAR REPAIR. ON (B)(6) 2018, THE PATIENT WAS BROUGHT TO THE HOSPITAL FOR EXCESSIVE BLEEDING AT THE CAROTID ENDARTERECTOMY INCISION SITE; IT WAS ALSO REPORTED THAT THE PATIENT SUFFERED A STROKE. THE PATIENT UNDERWENT SURGERY WHERE A 6 X 12 CM HEMATOMA WAS DRAINED, AND THE ECM WAS REPORTED TO BE SPLIT OR RUPTURED DOWN THE MIDDLE (NOT ALONG THE SUTURE LINE). THE ECM WAS REMOVED AND A BOVINE PERICARDIAL PATCH WAS SUTURED IN. THE INCISION WAS CLOSED AND THE PATIENT WAS ADMITTED. THE EVENT WAS INDICATED TO BE PROBABLY RELATED TO THE PROCEDURE AND PROBABLY RELATED TO THE DEVICE. THE PATIENT IS RECOVERING.

  Patient problems: Hematoma

  MAUDE report 7843483 ↗
• InjuryMay 2, 2018Material Distortion; Material Distortion

  IT WAS REPORTED THAT THE PATIENT, A (B)(6) MALE, UNDERWENT A RIGHT CAROTID ENDARTERECTOMY AT A CARDIOVASCULAR FACILITY ON (B)(6) 2017. THE ECM PATCH WAS SOAKED IN A SALINE SOLUTION FOR 1-2 MINUTES EXACTLY. A 2-4 WEEK FOLLOW UP WAS COMPLETED AND NO COMPLICATIONS WERE OBSERVED. AT A LATER DATE (SPECIFIC DATE UNKNOWN) THE PATIENT HAD AN ULTRASOUND/DUPLEX STUDY COMPLETED WHEN HE WAS GOING TO HAVE A COLONOSCOPY WITH ANOTHER PHYSICIAN. IT WAS NOTED AT THAT TIME THAT THERE WAS AN ANEURYSM PRESENT AT THE SITE OF ECM PATCH IMPLANT AND THE PATIENT WAS REFERRED BACK TO THE ORIGINAL CARDIOVASCULAR FACILITY. A CT ANGIOGRAM WAS PERFORMED ON (B)(6) 2018 AND IT WAS CONFIRMED THAT THE PATIENT HAD AN ANEURYSM AT THE SITE OF THE IMPLANTED ECM PATCH DEVICE AND THE SIZE WAS APPROXIMATELY 3CM X 2CM X 2CM CIRCULAR. CORRECTIVE SURGERY WAS PERFORMED ON (B)(6) 2018. THE ECM PATCH WAS OPENED UP AND THE SITE WAS CLEANED, HOWEVER IT CAN BE NOTED THAT THE ORIGINAL ECM PATCH WAS NOT FULLY EXPLANTED AND ONLY A SMALL PART (SPECIFIC SIZE UNKNOWN) OF THE CORMATRIX ECM PATCH WAS SENT TO HOSPITAL PATHOLOGY AND IT WAS CONFIRMED THE AREA WAS A TRUE ANEURYSM (NO RUPTURE/LEAK - ALL ENCAPSULATED). ANOTHER PATCH (BOVINE PER

  Patient problems: Aneurysm

  MAUDE report 7481148 ↗
• InjuryMar 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A CORMATRIX ECM (CMCV-013-609, LOT # M16G1183) WAS USED FOR A CAROTID PROCEDURE ON A (B)(6) FEMALE WITH AN IMPLANT DATE OF (B)(6) 2017 AND EVENT DATE/RE-OPERATED FOR A CAROTID ENDARTERECTOMY ON (B)(6) 2018 (ON WHICH DATE THE EXPLANT ALSO OCCURRED). IT IS STATED THAT THE ECM AND SOAK TIME WAS PREPARED "PER MANUFACTURER'S INSTRUCTIONS". THE EVENT WAS ORIGINALLY REPORTED AS, "CAROTID ARTERY ANEURYSM AT SITE OF IMPLANT. WORK UP IN PROGRESS WILL NEED ADDITIONAL STENT OR EXPLANT" (AS OF (B)(6) 2018). THE ECM WAS SUTURED TO THE PATIENT TISSUE. THE SURGEON BELIEVES THAT THE EVENT WAS PROBABLY RELATED TO THE PROCEDURE AND PROBABLY RELATED TO THE DEVICE.THE PROBABLE CAUSE IS LISTED AS, "PRODUCT DEGRADATION". THE FINAL OUTCOME OF THE PATIENT IS FAIR.

  Patient problems: Aneurysm

  MAUDE report 7375155 ↗
• InjuryMar 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A CORMATRIX ECM (CMCV-013-609, LOT # M15L1279) WAS USED FOR A CAROTID PROCEDURE (EXACT DETAILS UNKNOWN) ON A (B)(6) MALE WITH AN IMPLANT DATE OF (B)(6) 2015 AND DATE OF EVENT/EXPLANT ON (B)(6) 2018*. IT IS STATED THAT THE ECM AND SOAK TIME WAS PREPARED "PER MANUFACTURER'S INSTRUCTIONS". THE EVENT WAS ORIGINALLY REPORTED AS, "ANEURYSM OF CAROTID ARTERY AT SITE OF IMPLANT. WILL REQUIRE SURGICAL EXPLANT 2/2" (AS OF FORMS RECEIVED ON 2/5/2018). THE ECM WAS SUTURED TO THE PATIENT TISSUE. THE SURGEON BELIEVES THAT THE EVENT WAS PROBABLY RELATED TO THE PROCEDURE AND PROBABLY RELATED TO THE DEVICE. THE PROBABLE CAUSE IS LISTED AS, "PRODUCT DEGRADATION". *IT CAN BE NOTED THAT IT WAS STATED, "NEW GRAFT (NOT AZIYO/CORMATRIX) IMPLANTED WHICH IS NOW OCCLUDED WITHIN 2 WEEKS OF SECOND OPERATION THAT OCCURRED ON (B)(6) 2018. PATIENT IS DOING BAD."

  Patient problems: Aneurysm

  MAUDE report 7375141 ↗
• MalfunctionSep 6, 2017Delamination; Delamination

  IT WAS REPORTED THAT A (B)(6) MALE HAD A FEMORAL ENDARTERECTOMY ON (B)(6) 2017 USING MODEL #CMCV-014-609, LOT # M17E1119. PER THE FACILITY, "THE PATCH WAS OPENED AND PLACED ON THE BACK TABLE TO SOAK. ACCORDING TO THE TECH, ABOUT 10 MINUTES LAPSED (WHILE THE ECM WAS SOAKING IN SALINE SOLUTION) BEFORE THE SURGEON WAS READY TO SUTURE THE PATCH. AS HE WAS BEGINNING TO SEW IN THE PATCH, THE PRODUCT BEGAN TO DELAMINATE ALONG ONE OF THE ENDS AND THEN PEELED APART EASILY. THE ECM PATCH WAS DISCARDED. A NEW PATCH WAS OPENED, SOAKED FOR 1 MINUTE, AND SUTURED WITHOUT INCIDENT. THERE WERE NO OBVIOUS REPERCUSSIONS FOR THE PATIENT OTHER THAN ADDING 10 MINUTES TO THE CASE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6846868 ↗
• MalfunctionJun 2, 2017Delamination; Delamination

  IT WAS REPORTED THAT ON (B)(6) 2017 THE PHYSICIAN WAS PLACING THE CORMATRIX ECM FOR VASCULAR REPAIR PRODUCT OVER THE DEFECT AND STARTED SEWING IT IN PLACE. WHILE SUTURING IN PLACE, THE PHYSICIAN NOTICED THAT THE PRODUCT LAYERS HAD STARTED SEPARATING. PHYSICIAN STOPPED, REMOVED THE PRODUCT AND REPLACED IT WITH A DIFFERENT BRAND PRODUCT. THE MODEL AND LOT NUMBER USED ARE CMCV-014-609/ M16F1149. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6609836 ↗