ProxiCor for Pericardial Closure CMCV-060-402Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00859389005010), received between Apr 20, 2017 and Jun 26, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON 05/29/2020 THAT A PROXICOR FOR PERICARDIAL CLOSURE DEVICE (MODEL CMCV-003-402 LOT# M19E1211) WAS PLACED DURING A PROCEDURE PERFORMED ON (B)(6) 2020 TO CLOSE THE PERICARDIUM ON A (B)(6) MALE PATIENT. ONCE THE PROXICOR WAS IN PLACE, THE PATIENT DEVELOPED SYMPTOMS OF TAMPONADE. DECREASE IN BLOOD PRESSURE (BP), INCREASE IN CARDOVASCULAR PRESSURE (CVP) AND DECREASED LEFT VENTRICULAR (LV) FUNCTION. PROXICOR WAS REMOVED. PHYSICIAN STATED THAT THE PROBABLE CAUSE OF THE EVENT WAS TIGHTNESS DUE TO THE PROXICOR FOR PERICARDIAL CLOSURE DEVICE BEING PLACED. PATIENT IS RECOVERING FOLLOWING REMOVAL.

  Patient problems: Cardiac Tamponade

  MAUDE report 10202399 ↗
• InjuryJun 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 A PATIENT HAD CHEST WALL BLEEDING (TAMPONADE) POST AORTIC VALVE REPLACEMENT/CORONARY ARTERY BYPASS GRAFT (4 HOURS POST IMPLANT) WHERE THE PROXICOR WAS USED. THE PATIENT WAS BROUGHT BACK TO THE OR AND THE PROXICOR WAS REMOVED AND THE PATIENT'S PRESSURE WENT BACK UP. THE DEVICE WAS SOAKED IN SALINE FOR 2 MINUTES. THE PATIENT WAS NOTED AS BEING OBESE AND THIS COULD HAVE CONTRIBUTED TO THE EVENT. THE EVENT WAS NOTED AS PROBABLY BEING RELATED TO THE PROCEDURE AND PROBABLY BEING RELATED TO THE DEVICE. THE PROBABLE CAUSE OF THE EVENT WAS LISTED AS MOST LIKELY DUE TO PROXICOR/CLOSURE OF PERICARDIUM. THE PATIENT NO LONGER HAS TAMPONADE.

  Patient problems: Cardiac Tamponade

  MAUDE report 8732662 ↗
• InjuryJun 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A MITRAL VALVE REPLACEMENT WAS COMPLETED ON A (B)(6) MALE ON (B)(6) 2017 WITH USE OF ECM PATCHES THAT WAS SOAKED IN SALINE (SOAK TIME UNKNOWN). IT WAS REPORTED THAT THE PATIENT DEVELOPED A COUGH APPROXIMATELY A WEEK AFTER THE PROCEDURE. IN (B)(6) 2017 (SPECIFIC DATE UNKNOWN) A THORACENTESIS WAS COMPLETED AND FLUID WAS REMOVED FROM CHEST AREA. ON (B)(6) 2017 A CHAMBERLAIN PROCEDURE WAS COMPLETED AND IT WAS REPORTED THAT APPROXIMATELY 2/3 OF THE PATCH WAS REMOVED (SPECIFIC DETAILS ARE UNKNOWN). IT WAS REPORTED THAT THE POCKET OF FLUID WAS NOT A HEMATOMA BUT RATHER TURBID FLUID WITH NO INFECTION PRESENT (BASED FROM HOSPITAL PATHOLOGY).

  Patient problems: Reaction; Unspecified Infection

  MAUDE report 7562042 ↗
• InjuryDec 7, 2017Material Separation; Material Separation

  THE ECM WAS SOAKED FOR 'MIN' AND WAS SUTURED TO TENSION WITH 4-0 PROLENE SUTURE. NO DELAMINATION WAS OBSERVED. NO GLUE, PLATELET GEL, OR HEMOSTATIC AGENTS WERE USED. ECM WAS NOT ATTACHED TO A HOMOGRAFT OR SYNTHETIC DEVICE. TWO (2) MONTHS AFTER IMPLANTATION PATCH FAILED/DEHISCED. A REOPERATION WITH AUTOLOGOUS PERICARDIUM WAS COMPLETED (EXPLANT DATE NOT PROVIDED). SAMPLE IS NOT AVAILABLE FOR EVALUATION. FINAL PATIENT OUTCOME: DOING WELL. THE SURGEON BELIEVES THE EVENT WAS RELATED TO THE DEVICE AND STATES "MOST LIKELY, BUT IMPOSSIBLE TO PROVE". ADDITIONAL ATTEMPTS TO GATHER INFORMATION WERE REQUESTED OF THE SITE ON 11/9/2017 AND 11/15/2017 WITH NO SUCCESS.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7096416 ↗
• InjuryNov 16, 2017Material Distortion; Material Distortion

  THE PATIENT IS A (B)(6) MALE ((B)(6)) THAT HAD AN ECM (PERICARDIAL CLOSURE 7X15 - CMCV-060-402 LOT # M17B1031) IMPLANTED ON (B)(6) 2017. THE ECM WAS SOAKED IN NORMAL SALINE FOR 2 MINUTES. THE DEVICE WAS USED FOR A FEMORAL ARTERY PATCH ANGIOPLAST WITH A 6-0 PROLENE SUTURE. THE GRAFT WAS SEWN TO NATIVE ARTERY. ON (B)(6) 2017 PATIENT PRESENTED TO THE DOCTOR'S OFFICE WITH PSEUDOANEURYSM. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND THE CORMATRIX PATCH WAS OBSERVED TO HAVE WHAT APPEARED TO BE A "CUT" RIGHT DOWN THE MIDDLE. THAT SECTION WAS REPAIRED WITH A 1X10 CAROTID PATCH (CAROTID REPAIR ECM -LOT # M17D1093) THAT WAS SEWN INTO THE EXISTING ECM 7X15 PC PATCH AROUND THE AREA OF THE "CUT". THE PATIENT REMAINED IN THE HOSPITAL FOR OBSERVATION. ON (B)(6) 2017, THE PATIENT EXPERIENCED ANOTHER PSEUDOANEURYSM. THE 7X15 WAS LEAKING PROXIMAL AND AWAY FROM INITIAL LEAK AREA IN A NEW AREA OF THE 7X15 PATCH, NOT NEAR THE ORIGINAL SUTURE LINES OR THE SUTURE REPAIR LINES WITH THE 1X10. ON (B)(6) 2017, THE DOCTOR REMOVED BOTH ECM CORMATRIX PATCHES AND USED A BOVINE PERICARDIAL PATCH FOR REPAIR. THE PATIENT IS OBSERVED TO BE RECOVERING WELL. THE DOCTOR THINKS THAT IT COULD POSSIBLY BE RELATED TO TH

  Patient problems: Pseudoaneurysm

  MAUDE report 7039236 ↗
• InjuryApr 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CORMATRIX ECM FOR PERICARDIAL CLOSURE (MODEL CMCV-060-402, LOT #M15F1167) WAS USED ON A (B)(6) MALE PATIENT WEIGHING (B)(6). THE 7CM X 15CM PIECE OF ECM WAS USED IN AN AORTIC ARCH RECONSTRUCTION PROCEDURE IN THE LEFT CHEST ON (B)(6) 2015. THE PATCH HAD BEEN HYDRATED IN A SALINE SOLUTION FOR APPROXIMATELY TWO MINUTES. APPROXIMATELY ONE YEAR LATER, ON (B)(6) 2016, A RESECTION OF THE DILATED CORMATRIX CONDUIT WAS COMPLETED AND REPLACED WITH A GORETEX CONDUIT. THERE WAS NO INITIAL ONSET OF SYMPTOMS OR SERIOUS ADVERSE EVENT/MALFUNCTION THAT DICTATED THE RESECTION AND REPLACEMENT OF THE CORMATRIX ECM. THE PHYSICIAN DETERMINED DURING SUBSEQUENT FOLLOW-UP THAT THE AORTIC REPAIR APPEARED DILATED AND POSITED THAT THE DILATION MAY BE THE EARLY SIGNS OF AN ANEURYSM AND DECIDED TO RE-OPERATE AND REPLACE. UPON RE-OPENING PATIENT, SURGEON DETERMINED THAT THE CORMATRIX PATCH HAD COMPLETELY INTEGRATED AND WAS STILL STRONG, BUT WAS JUST OVERGROWN TO DOUBLE THE DIAMETER OF THE PATIENT'S AORTA. NO STENOSIS WAS OBSERVED. THE EXPLANTED ECM WAS SENT TO HOSPITAL PATHOLOGY FOR EVALUATION.

  Patient problems: No Information

  MAUDE report 6509130 ↗