MAUDE Adverse Event Report: CORMATRIX CARDIOVASCULAR, INC. CORMATRIX ECM FOR PERICARDIAL CLOSURE; PATCH, PLEDGET AND INTRACARDIAC

Model Number	CMCV-003-401
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	04/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported events indicate the patient was admitted to hospital on (b)(6) 2017 for possible wound infection in groin for treatment utilizing a wound vacuum, and on (b)(6) 2017 the implanted ecm material was removed during exploration surgery following acute bleed which occurred during that hospitalization.Redacted medical records indicate the device used in this endarterectomy was a cmcv-004-401 cormatrix ecm for cardiac tissue repair (7cm x 10cm), however manufacturing lot number provided is a cmcv-003-401 cormatrix ecm for pericardial closure (7cm x 10cm).Shipping records confirm the cormatrix ecm for pericardial closure device being shipped to the facility.In neither case are the identified products indicated for the reported vascular repair.The site investigator for the hospital states that the reported event was not related to the cormatrix device or the procedure.A review of manufacturing records shows that this lot was released to distribution on 9/14/2016 having met all internal quality requirements for release with no non-conformances or deviations occurring during production.The root cause of the product explant performed as a result of an acute bleed developing during wound vac treatment is unknown.Additional requests have been made to the facility for clarification, as well as requesting the results of wound cultures.If additional relevant details are provided, a follow-up report will be submitted.
Event or Problem Description
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 while being hospitalized for possible wound infection.".

• Brand Name: CORMATRIX ECM FOR PERICARDIAL CLOSURE
• Common Device Name: PATCH, PLEDGET AND INTRACARDIAC
• Manufacturer (Section D): CORMATRIX CARDIOVASCULAR, INC.; 1100 old ellis road; roswell GA 30076
• MDR Report Key: 6541311
• Report Number: 3005619880-2017-00014
• Device Sequence Number: 13603656
• Product Code: DXZ
• UDI-Device Identifier: 10859389005000
• UDI-Public: 10859389005000
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K051405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: CMCV-003-401
• Device Lot Number: M16K1240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR