FDA Adverse Event Malfunction Summary report: N

CORMATRIC ECM FOR VASCULAR REPAIR

MDR report key: 6048777 · Received October 21, 2016

Report

Report Number: 3005619880-2016-00031
Event Type: Malfunction
Date Received: October 21, 2016
Date of Event: September 19, 2016
Report Date: October 21, 2016
Manufacturer: CORMATRIX CARDIOVASCULAR, INC.
Product Code: DXZ
UDI-DI: 10859389005147
PMA / PMN Number: K140789
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

REVIEW OF MANUFACTURING RECORDS FOR LOT M16D1130 SHOWED THAT LOT WAS DETERMINED TO HAVE MET ALL MANUFACTURING AND QUALITY RELEASE SPECIFICATIONS AND RELEASED TO DISTRIBUTION ON 4/29/2016. INSTRUCTIONS FOR USE FOR CORMATRIX ECM FOR VASCULAR REPAIR (P/N 20438-032514) STATE UNDER SUGGESTED INSTRUCTIONS FOR USING THE CORMATRIX ECM THAT "IF REQUIRED, THE CORMATRIX ECM CAN BE CUT TO THE APPROPRIATE SIZE....IF DELAMINATION IS OBSERVED, DO NOT IMPLANT THE CORMATRIX ECM".

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2016, A 1CM X 10CM PIECE OF CORMATRIX ECM FOR VASCULAR REPAIR (LOT# M16D1130 EXP. DATE 2017-09-30) WAS HYDRATED FOR 2 - 3 MINUTES AND WHEN PHYSICIAN REMOVED THE ECM STRIP FROM THE BOWL, IT HAD DELAMINATED ON THE EDGES AND WAS NOT USED IN THE PROCEDURE. PHYSICIAN TOOK ANOTHER ECM UNIT FROM THE SAME LOT AND USED IT SUCCESSFULLY IN THE PROCEDURE WITH NO FURTHER ISSUES REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
699825	CORMATRIC ECM FOR VASCULAR REPAIR	PATCH, PLEDGET AND INTRACARDIAC	DXZ	CORMATRIX CARDIOVASCULAR, INC.	CMCV-014-609	M16D1130	10859389005147

Patients

Seq	Age	Sex	Outcome	Treatment
1