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ProxiCor for Pericardial Closure CMCV-059-401Recalls & reported problems

Elutia Med LLC · ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery. · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00859389005003), received between May 3, 2017 and May 3, 2017 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Post Operative Wound Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A (B)(6) WHITE FEMALE WITH HISTORY OF DIABETES, HYPERTENSION, PREVIOUS GROIN SURGERY AND A CURRENT SMOKER, WITH A FONTAINE CLASS III CLASSIFICATION FOR PERIPHERAL ARTERY DISEASE, UNDERWENT A FEMORAL ENDARTERECTOMY WITH ECM LOT # M16K1240 ON (B)(6) 2017. AT THE 4-6 WEEK VISIT ON (B)(6) 2017 THE PATIENT RECORD NOTES THAT THE LEFT GROIN HAS SLOW HEALING AND A HIGH AMOUNT OF LYMPHATIC DRAINAGE. WOUND VAC RECOMMENDED AND SCHEDULED. STUDY COORDINATOR WAS NOTIFIED ON (B)(6) 2017 THAT SUBJECT WAS BEING ADMITTED TO HOSPITAL FOR CONCERN FOR POST-OPERATIVE INFECTION OF GROIN WOUND. ON (B)(6) 2017 STUDY COORDINATOR INFORMED CORMATRIX THAT SUBJECT HAD A POSSIBLE EXPLANT OF PATCH AND A SARTORIUS FLAP CLOSURE. ON (B)(6) 2017 IT WAS CLARIFIED WITH CLINICAL COORDINATOR THAT THE PATIENT HAD A HISTORY OF RADIATION TO THE GROIN AREA DUE TO VULVAR CANCER. ALSO, PER THE ADVERSE EVENT FORM COMPLETED BY THE SITE INVESTIGATOR STATES THAT THE EVENT WAS NOT RELATED TO THE PROCEDURE AND NOT RELATED TO THE ECM DEVICE. THE ECM DEVICE WAS REMOVED DURING LEFT WOUND EXPLORATION ON (B)(6) 2017. THE REASON FOR THE EXPLORATION WAS LISTED AS, "SUBJECTS PATCH WAS EXPLANTED DURING EXPLORATION FOLLOWING AN ACUTE BLEED WH

    Patient problems: Post Operative Wound Infection

    MAUDE report 6541311 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.