MAUDE Adverse Event Report: CORMATRIX CARDIOVASCULAR, INC. CORMATRIX ECM FOR VASCULAR REPAIR; PATCH, PLEDGET AND INTRACARDIAC, PETP

Model Number	CMCV-011-606
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of manufacturing lot history record shows that the reported lot was released to distribution on 12/13/2016 having met all manufacturing and quality release requirements including product sterility testing.There were no manufacturing deviations or non-conformances associated with the production of this lot.A review of the complaint log shows that this is the only complaint associated with this reported lot number.
Event or Problem Description
It was reported that an ecm for vascular repair (cmcv-012-606 lot m16n1320) was used on a (b)(6) male patient who developed a "infected right femoral area." the ecm had been soaked for approx.30 seconds and used in a right femoral endarterectomy with right iliac stent utilizing a 6.0 prolene suture on (b)(6) 2017.The patient was discharged.The patient then returned for a re-do procedure on (b)(6) 2017.Per redacted medical records, on (b)(6) 2017 the following procedures were performed: "angiography of right femoral area prior to starting the procedure and used for control of iliac artery, exploration of right femoral area, debridement of artery and previously placed patch down to the external iliac and profunda femoral artery, right external iliac to profunda femoral bypass using superficial femoral artery, a satorius flap for coverage.".

• Brand Name: CORMATRIX ECM FOR VASCULAR REPAIR
• Common Device Name: PATCH, PLEDGET AND INTRACARDIAC, PETP
• Manufacturer (Section D): CORMATRIX CARDIOVASCULAR, INC.; 1100 old ellis road; roswell GA 30076
• MDR Report Key: 6609833
• Report Number: 3005619880-2017-00021
• Device Sequence Number: 1149118
• Product Code: DXZ
• UDI-Device Identifier: 10859389005123
• UDI-Public: 10859389005123
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140789
• 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): 06/02/2017

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: 02/28/2018
• Device Model Number: CMCV-011-606
• Device Lot Number: M16N1320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2017
• Initial Report FDA Received Date: 06/02/2017
• 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: 59 YR