FDA Adverse Event Malfunction Summary report: N

CORMATRIX ECM FOR VASCULAR REPAIR

MDR report key: 4951709 · Received July 28, 2015

Report

Report Number: 3005619880-2015-00037
Event Type: Malfunction
Date Received: July 28, 2015
Date of Event: July 6, 2015
Report Date: July 6, 2015
Manufacturer: CORMATRIX CARDIOVASCULAR, INC.
Product Code: DXZ
PMA / PMN Number: K140789
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE REMAINS IMPLANTED. NO SAMPLE IS AVAILABLE FOR EVALUATION. MANUFACTURING RECORDS FOR LOT M15C1080 HAVE BEEN REVIEWED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE COMPLAINT LOG INDICATED THAT THIS IS THE ONLY COMPLAINT FOR DELAMINATION OR FUNCTIONAL ISSUES ASSOCIATED WITH LOT M15C1080 TO DATE.

Description of Event or Problem · 1

ON 07/06/2015, CORMATRIX CARDIOVASCULAR BECAME AWARE OF AN EVENT INVOLVING THE USE OF CORMATRIX ECM FOR VASCULAR REPAIR AND A REPORTED CASE OF DELAMINATION. DETAILS OF THE EVENT ARE PROVIDED BELOW. IT WAS REPORTED THAT THE CORMATRIX ECM FOR VASCULAR REPAIR DELAMINATE IN A VERY SMALL AREA ALONG ONE EDGE. THE PATCH HAD BEEN SOAKED IN ROOM TEMPERATURE SALINE FOR APPROXIMATELY 1 MINUTE PRIOR TO SUTURING. THE DELAMINATION WAS NOTICED BY THE SURGEON DURING PLACEMENT OF THE FINAL 2 STITCHES. IT WAS REPORTED THAT THE SURGEON INDICATED THAT HE WAS NOT CONCERNED BECAUSE IT WAS IN A VERY SMALL AREA. THE SURGEON TOOK LARGE SUTURE BITES AND CONTINUED TO USE THE PRODUCT. NO SURGICAL DELAYS OR COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
488075	CORMATRIX ECM FOR VASCULAR REPAIR	PATCH, PLEDGET, INTRACARDIAC, PETP	DXZ	CORMATRIX CARDIOVASCULAR, INC.	CMCV-013-609	M15C1080

Patients

Seq	Age	Sex	Outcome	Treatment
1