CanGaroo Envelope CMCV-009-MEDRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00859389005034), received between Jan 21, 2016 and Sep 23, 2026 — classified as 32 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this bioenvelope was part of a system revision due to infection. There were no additional adverse patient effects reported. The bioenvelope was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50872732 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EMAIL FROM SALES REP WITH ADVERSE EVENT REPORT AS FOLLOWS: POCKET INFECTION. PATIENT HAD NEW BIV PACEMAKER PLACED ON (B)(6) 2023 WITH CANGAROO DEVICE (MODEL # CMCV-009-MED, LOT #M23G1206). ON (B)(6) 2023, PATIENT WAS SEEN IN OFFICE AND NOTED TO HAVE A POCKET HEMATOMA. FLUID FROM HEMATOMA WAS DRAINED AND CULTURED, WITH RESULTS POSITIVE FOR ENTEROCOCCUS AND E. COLI. PATIENT STARTED ON ANTIBIOTICS AND SENT HOME. DOCTOR REPORTED ON (B)(6) 2023 THAT PATIENT'S WOUND WAS GETTING WORSE AND HE PLANNED HOSPITAL ADMISSION FOLLOWING UPCOMING OFFICE VISIT. EVENT REPORTED AS "POSSIBLY RELATED" TO CANGAROO ENVELOPE AS WELL AS THE PROCEDURE TO IMPLANT IT. PHYSICIAN STATED CAUSE MAY BE RELATED TO SURGICAL TECHNIQUE AS HE HAD A SECOND PATIENT (WITHOUT CANGAROO DEVICE) WHO DEVELOPED INFECTION WITH THE SAME BACTERIA.

  Patient problems: Unspecified Infection

  MAUDE report 18143126 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EMAIL WAS RECEIVED FROM THE AZIYO CLINICAL RESEARCH MANAGER REGARDING A PATIENT IN AN (B)(6) STUDY. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT HAD A DE NOVO PACEMAKER IMPLANT WITH THE IMPLANT OF AN AZIYO CANGAROO ENVELOPE (MODEL CMCV-009-MED, LOT M21H1305). ON (B)(6) 2021, SITE BECAME AWARE THAT THE PATIENT DEVELOPED AN INFECTION IN THE POCKET AND WAS TREATED WITH ORAL ANTIBIOTICS (MINOCYCLINE FOR 10 DAYS) AND EVENT RESOLVED WITHOUT SEQUELAE BY (B)(6) 2021. PHYSICIAN NOTED THAT PATIENT PULLED ON INTERNAL SUTURE, POTENTIALLY OPENING THE POCKET. NO FURTHER DETAILS ARE AVAILABLE REGARDING THIS EVENT BUT IF AZIYO RECEIVES MORE INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Bacterial Infection

  MAUDE report 13497431 ↗
• InjuryOct 11, 2021No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2021, AZIYO WAS NOTIFIED BY BUSINESS PARTNER BOSTON SCIENTIFIC THAT A PATIENT WITH A CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) SYSTEM HAD A "POCKET REVISION DUE TO INFECTION" ON (B)(6) 2021. THE REVISION INCLUDED THE EXPLANTATION OF THE AZIYO BIOLOGICS CANGAROO ENVELOPE (MODEL CMCV-009-MED, LOT M21F1242, SERIAL NUMBER (B)(4)). BASED ON THE SMALL AMOUNT OF INFORMATION OBTAINED FROM BOSTON SCIENTIFIC, IT APPEARS THE IMPLANTATION AND EXPLANTATION OF THIS DEVICE WAS DONE ON THE SAME DAY. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PHYSICIAN FOR MORE DETAILS. THE PHYSICIAN RELAYED A MESSAGE THAT STATED THAT THE POCKET REVISION WAS "NOT INFECTION-RELATED." NO FURTHER DETAILS ARE ANTICIPATED.

  Patient problems: Insufficient Information

  MAUDE report 12605044 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, PATIENT UNDERWENT A PROCEDURE TO REPLACE A GENERATOR USING AN AZIYO BIOLOGICS CANGAROO ENVELOPE (MODEL CMCV-009-MED, LOT NUMBER M20D1134). ON (B)(6) 2021, PATIENT HAS THE ICD AND AZIYO ENVELOPE EXPLANTED BY A DIFFERENT DOCTOR DUE TO EROSION AT THE SUTURE LINE. EROSION DESCRIBED AS 'THE SIZE OF A PENCIL ERASER" WITH ONE OF THE LEADS VISIBLE THROUGH THE OPENING. THERE WAS NO DRAINAGE OR ACTIVE INFECTION VISIBLE. SURGEON STATED THAT THE EROSION WAS LIKELY DUE TO THE SMALL POCKET THAT HAD BEEN CREATED FOR THE DEVICE AND SCAR TISSUE AT THE SUTURE-LINE DUE TO TWO PREVIOUS ACCESSES USING THE SITE. PATIENT WAS REIMPLANTED WITH A NEW SYSTEM ON THE OPPOSITE SIDE OF HIS CHEST. PATIENT WAS ALSO PRESCRIBED IV ANTIBIOTICS.

  Patient problems: Pocket Erosion

  MAUDE report 12532283 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AZIYO'S BUSINESS PARTNER, BOSTON SCIENTIFIC, THAT A CANGAROO ENVELOPE (MODEL #: CMCV-009-MED / LOT #: M20G1215) WAS EXPLANTED ON (B)(6) 2021 DUE TO INFECTION. ADDITIONAL INFORMATION RECEIVED FROM BUSINESS PARTNER REPORTED THAT THIS WAS AN "INFECTION WITH SEPSIS" AND THE PATIENT WAS PLACED ON IV ANTIBIOTICS. THE INITIAL IMPLANT OF THE CANGAROO ENVELOPE AND PACEMAKER WAS PERFORMED ON (B)(6) 2021. MULTIPLE ATTEMPTS WERE MADE TO CONFIRM SEPSIS REPORT AND TO GET ADDITIONAL INFORMATION FROM IMPLANTING PHYSICIAN, BUT WERE UNSUCCESSFUL. SHOULD AZIYO RECEIVE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT, AN UPDATE REPORT WILL BE SUBMITTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 11987144 ↗
• InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021 BY AZIYO BUSINESS PARTNER BIOTRONIK THAT A CANGAROO ENVELOPE (MODEL CMCV-009-MED, LOT# M20N1418) WAS USED IN AN INITIAL PACEMAKER IMPLANT PROCEDURE ON (B)(6) 2021 ON A FEMALE PATIENT. ENVELOPE WAS PREPARED BY SOAKING IN SALINE FOR 1 - 2 MINUTES. PATIENT WAS SEEN IN EMERGENCY DEPARTMENT ON (B)(6) 2021 WITH SWELLING AND BRUISING AROUND HER PACEMAKER AND POTENTIAL ENVELOPE INFECTION. THE PATIENT WAS PLACED ON IV ANTIBIOTICS. DEVICE WAS EXPLANTED (B)(6) 2021 AND PATIENT IS BEING RE-EVALUATED IF ANOTHER DEVICE WILL BE IMPLANTED AT A LATER DATE. NO FURTHER INFORMATION WAS PROVIDED DESPITE REQUESTS FOR ADDITIONAL DETAILS. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 11958003 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AZIYO BIOLOGICS' BUSINESS PARTNER BOSTON SCIENTIFIC, THAT A CANGAROO ENVELOPE (MODEL CMCV-009-MED LOT #M20D1137) WAS USED WITH A BOSTON SCIENTIFIC DEVICE (MODEL # / SERIAL # UNKNOWN) AND IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020 THE DEVICE AND CANGAROO POUCH WERE EXPLANTED DUE TO A LEAD REVISION PROCEDURE REQUIRED DUE TO HIGH PACING THRESHOLDS. A NEW DEVICE AND CANGAROO ENVELOPE WERE IMPLANTED. THIS ISSUE WAS REPORTED TO AZIYO BIOLOGICS BY BOSTON SCIENTIFIC ON 10/22/2020 AND FURTHER INFORMATION RECEIVED ON 11/18/2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10861895 ↗
• MalfunctionOct 7, 2020Material Separation; Therapeutic or Diagnostic Output Failure

  THIS WAS AN INITIAL IMPLANT OF A PACEMAKER: THE SCRUB TECH OPENED AND PREPARED THE EQUIPMENT PER MANUFACTURER'S INSTRUCTIONS WHILE IN THE ROOM WITH THE PHYSICIAN. AFTER THE PREPARATION TIME, THE DEVICE POUCH WAS HANDED TO THE IMPLANTING PHYSICIAN. AT THIS TIME THE PHYSICIAN ATTEMPTED TO OPEN THE DEVICE FOR USE. THE SUTURES THAT ARE ATTACHED TO THE DEVICE IN PACKAGING BEGAN TO DISSOLVE/FALL AWAY FROM THE POUCH OPENING. SUBSEQUENTLY, THE POUCH SEPARATED ON ITSELF AND WAS NOT DEEMED USABLE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10648922 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AZIYO BIOLOGICS' BUSINESS PARTNER BOSTON SCIENTIFIC, THAT A CANGAROO ENVELOPE (MODEL CMCV-009-MED LOT# M20B1078) WAS USED WITH A BOSTON SCIENTIFIC DEVICE (MODEL #/SERIAL # UNKNOWN) AND IMPLANTED ON (B)(6) 2020. PATIENT DEVELOPED AN INFECTION AND ON (B)(6) 2020 THE ENTIRE SYSTEM WAS EXPLANTED. THE ISSUE WAS REPORTED TO AZIYO BIOLOGICS ON (B)(6) 2020.

  Patient problems: Unspecified Infection

  MAUDE report 10554903 ↗
• InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AZIYO BIOLOGICS' BUSINESS PARTNER BOSTON SCIENTIFIC, THAT A CANGAROO ENVELOPE (MODEL CMCV-009-MED LOT# M20B1068) WAS USED WITH A BOSTON SCIENTIFIC PACEMAKER (MODEL #/SERIAL # UNKNOWN) AND IMPLANTED ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2020 DUE TO INFECTED PACEMAKER WITH WOUND DEHISCENCE. THE ENTIRE SYSTEM, INCLUDING THE AZIYO CANGAROO ENVELOPE WERE EXPLANTED ON 7/1/2020. WOUND WAS IRRIGATED WITH ANTIBIOTIC SOLUTION AFTER EXPLANTING THE DEVICE. THE ISSUE WAS REPORTED TO AZIYO BIOLOGICS ON 8/18/2020.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 10541396 ↗
• InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AZIYO BIOLOGICS' BUSINESS PARTNER BOSTON SCIENTIFIC, THAT A CANGAROO ENVELOPE (MODEL CMCV-009-MED LOT# M20C1091) WAS USED WITH A BOSTON SCIENTIFIC DEVICE (MODEL #/SERIAL # UNKNOWN) AND IMPLANTED ON (B)(6) 2020. PATIENT DEVELOPED AN INFECTION AND ON (B)(6) 2020 THE ENTIRE SYSTEM WAS EXPLANTED. A NEW SYSTEM WAS IMPLANTED AT THE SAME TIME ON THE OPPOSITE SIDE OF PATIENT'S CHEST. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND HAS SINCE RECOVERED. THE ISSUE WAS REPORTED TO AZIYO BIOLOGICS ON 7/24/2020 WITH ADDITIONAL DETAIL PROVIDED ON 8/05/2020.

  Patient problems: Unspecified Infection

  MAUDE report 10436005 ↗
• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AZIYO BIOLOGICS' BUSINESS PARTNER BOSTON SCIENTIFIC, THAT A CANGAROO ENVELOPE (MODEL CMCV-009-MED LOT #M19M1481) WAS USED WITH A BOSTON SCIENTIFIC DEVICE (MODEL # / SERIAL # UNKNOWN) AND IMPLANTED ON (B)(6) 2020. IT WAS REPORTED THAT THIS ACCESSORY PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION NOTED ON (B)(6) 2020, AND THE ENTIRE SYSTEM WAS EXPLANTED ON (B)(6) 2020. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS WHICH WERE ADMINISTERED ON THE DAY OF THE PROCEDURE. THE EXPLANTED DEVICE WAS SENT TO PATHOLOGY FOR CULTURE, BUT NO RESULTS PROVIDED BY THE INITIAL REPORTER.

  Patient problems: Unspecified Infection

  MAUDE report 10344905 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS AN (B)(6) WOMAN WITH A PACEMAKER AND AN AZIYO PRODUCT IMPLANTED ON (B)(6) 2019. THE POCKET WAS BLEEDING AND ERODED OUT OF THE SKIN. THE DEVICE WAS PROTRUDING. BECAUSE OF THIS, THE PATIENT WAS REFERRED FOR DEVICE AND LEAD REMOVAL FOR POSSIBLE DEVICE AND LEAD INFECTION. GOALS AND RISKS WERE DISCUSSED.

  Patient problems: Pocket Erosion

  MAUDE report 9795265 ↗
• InjuryFeb 26, 2020Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem; Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem

  PRODUCT WAS PART OF A SYSTEM REVISION ON (B)(6) 2020 DUE TO CONTAMINATION ISSUES.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 9758566 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CALLED HEALTH CARE PROVIDER AND SAID THEY WERE NOT FEELING WELL. PATIENT HAD BEEN HAVING DRY HEAVES AND VOMITING MOST OF THE WEEKEND. NOTE: HAD USED CANGAROO POUCH AT INITIAL CASE, NOTHING HAD REALLY CHANGED, DR REMOVED DEVICE.

  Patient problems: Vomiting

  MAUDE report 9726534 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE WAS PART OF A SYSTEM REVISION DUE TO INFECTION WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 9726518 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SYSTEM WAS REMOVED DUE TO INFECTION WITH SEPSIS. REPORTEDLY, NECROSIS WAS FOUND AFTER THEY OPENED POCKET. THE PHYSICIAN THOUGHT IT WAS AN ALLERGIC REACTION TO THE DEVICE. POCKET AREA WAS ALL BLACK; ALL NECROTIC TISSUE. SUBSEQUENTLY, THE PHYSICIAN REMOVED EVERYTHING (ELECTRONIC DEVICE AND CANGAROO ENVELOPE).

  Patient problems: Necrosis; Sepsis; Unspecified Infection

  MAUDE report 9681968 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AZIYO CANGAROO ENVELOPE DEVICE WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 9681955 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION ON (B)(6) 2019 DUE TO INFECTION AND EROSION. REPORTEDLY, THE PATIENT'S ABDOMINAL IMPLANT ERODED THROUGH THE PATIENT'S SKIN AND SEVERAL LABORATORIES WITH THE DEVICE WERE DONE. PATIENT DEVICE WAS EXPLANTED, AND A NEW PACEMAKER WAS IMPLANTED. SEVERAL LABORATORIES WITH THE DEVICE WERE PERFORMED WHICH PROMPTED THE PHYSICIAN TO EXTRACT THE PATIENT'S DEVICE. LEADS AND CANGAROO ENVELOPE REMAINED IN SERVICE. IT CAN BE NOTED THAT THE INITIAL REPORTER STATED THE AZIYO DEVICE WAS NOT RELATED TO THE EVENT. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 9681950 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CANGAROO ENVELOPE WAS PART OF A SYSTEM THAT WAS EXPLANTED DUE TO INFECTION WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 9681403 ↗
• InjuryJul 30, 2019Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  A MALE PATIENT (AGE UNKNOWN) UNDERWENT AN UPGRADE TO A BIV PACEMAKER WITH CANGAROO ENVELOPE ON (B)(6) 2019. THE LV LEAD DISLODGED AND LEAD REVISION WAS PERFORMED ON (B)(6) 2019. THE INCISION WAS OPENED AND EXCESSIVE FLUID WAS NOTED DRAINING FROM THE POCKET, WHICH APPEARED TO BE A MIXTURE OF BLOOD AND A PUS-LIKE SUBSTANCE. CULTURES WERE TAKEN OF THIS FLUID. ONCE THE FLUID WAS CLEARED FROM THE POCKET, CULTURES WERE OBTAINED ON A PORTION OF THE POUCH. TOTAL SYSTEM EXTRACTION (TO INCLUDE BIV PACEMAKER AND CANGAROO ENVELOPE) WAS ON (B)(6) 2019. THE PATIENT WAS RE-IMPLANTED WITH A BIV ICD ON (B)(6) 2019 ON THE RIGHT SIDE OF THE CHEST (WITHOUT CANGAROO). NASAL SCREEN ON (B)(6) 2019 CONFIRMED CHRONIC (B)(6). ALL LAB RESULTS/CULTURES RESULTED AS NEGATIVE. PATIENT DISCHARGED FROM HOSPITAL ON (B)(6) 2019 WITH DOXYCYCLINE 14-DAY TREATMENT (FOR (B)(6)). FINAL ASSESSMENT FROM THE EP TEAM IS THAT THE POCKET WAS NOT INFECTED. HOWEVER, FOCUS WAS PLACED ON THE PURULENT EXUDATE AND THEY ASSUME THE PATIENT HAD SOME TYPE OF NON-INFECTIOUS REACTION TO THE POUCH UTILIZED DURING THE SYSTEM UPGRADE ON (B)(6) 2019.

  Patient problems: Reaction

  MAUDE report 8841103 ↗
• InjuryAug 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL INFORMATION RECEIVED ON 1/30/2017: AE#1 - IT WAS REPORTED THAT A CANGAROO ECM ENVELOPE WAS USED ON A (B)(6) WHITE MALE WITH RISK FACTORS OF SYSTEMIC ANTICOAGULANTS, RENAL INSUFFICIENCY AND SMOKER. IMPLANT PROCEDURE WAS ON (B)(6) 2017 AND A PM WAS PLACED. ECM WAS SOAKED IN GENTAMYCIN AND IV ANTIBIOTIC GIVEN PRE-OPERATIVELY. ON (B)(6) 2017 SUBJECT WAS ADMITTED TO THE HOSPITAL FOR THROMBOCYTOPENIA (PAST MEDICAL HISTORY OF THIS) WITH PLATELETS AT 111. HE ALSO WAS NOTED TO HAVE A HEMATOMA AT THIS TIME. IT IS CURRENTLY UNKNOWN IF THE EVENTS ARE RELATED TO THE CORMATRIX DEVICE OR PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 2/1/2017 ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE TWO RECURRENT EVENTS FOR HEMATOMA'S. AE#1 ON (B)(6) 2017 THE PATIENT WAS ADMITTED FOR THROMBOCYTOPENIA AND WAS GIVEN A PLATELET INFUSION. THE SITE INVESTIGATOR STATES THAT THE EVENT'S PROBABLE CAUSE WAS THERAPEUTIC COUMADIN AND ANTICOAGULATION WITH PLATELET DYSFUNCTION. AE#2 ON (B)(6) 2017 THE PATIENT WAS HOSPITALIZED DUE TO RECURRING HEMATOMA AND IT WAS DECIDED THAT THE PATIENT NEEDED A POCKET REVISION AND EXPLORATION. THE ECM POUCH WAS REMOVED AND THE EVENT WAS CONCLUDED BY INVESTIGA

  Patient problems: Hematoma

  MAUDE report 7806686 ↗
• MalfunctionNov 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SUBJECT IS A (B)(6) FEMALE WHO HAD AN INITIAL ST. JUDE MEDICAL PACEMAKER IMPLANTED WITH ECM (CMCV-009-MED, LOT# M17A1005) ON (B)(6) 2017. AT THE (B)(6) 2017 WOUND CHECK VISIT SUBJECT HAD "LEFT PECTORAL REGION OF CHEST WOUND WITH SMALL FIRM HEMATOMA AND YELLOW BRUISING PRESENT." HEMATOMA REMAINED AT THE 4-6 WEEK VISIT ON (B)(6) 2017 AND WAS RESOLVED AT THE 3 MONTH FOLLOW-UP VISIT ON (B)(6) 2017 THE EVENT RESOLVED WITHOUT SEQUELAE WITH NO MEDICAL INTERVENTION. THE SITE INVESTIGATOR STATES THAT THE EVENT IS POSSIBLY RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE DEVICE. THE PROBABLE CAUSE OF THE EVENT IS LISTED AS, "PROCEDURE".

  Patient problems: Hematoma

  MAUDE report 7045086 ↗
• InjuryMay 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE WITH A HISTORY OF MALIGNANCY AND POCKET RE-ENTRY (WITHIN 2 WEEKS OF INITIAL IMPLANT), LEFT BUNDLE BRANCH BLOCK AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE HAD A DUAL CHAMBER PACEMAKER IMPLANTED ON (B)(6) 2017 USING A CORMATRIX CANGAROO ECM ENVELOPE (CMCV-009-MED LOT # M16N1322), HYDRATED WITH VANCOMYCIN AND GENTAMYCIN. PATIENT REQUIRED AN RV LEAD REVISION DUE TO DISLODGEMENT ON (B)(6) 2017. ON (B)(6) 2017 SUBJECT PRESENTED AT THE EMERGENCY DEPARTMENT AND WAS DIAGNOSED WITH SEROMA/HEMATOMA AT THE PACEMAKER SITE. THIS SITE INVESTIGATOR DETERMINED THAT THE EVENT WAS POSSIBLY RELATED TO CANGAROO ECM AND PROBABLY RELATED TO THE PROCEDURE. THE PROBABLE CAUSE OF THE EVENT WAS LISTED AS, "SEROMA/HEMATOMA AT PACEMAKER SITE".

  Patient problems: Seroma

  MAUDE report 6565141 ↗