FDA Adverse Event Injury Summary report: N

VASCU-GUARD PERIPHERAL VASCULAR PATCH

MDR report key: 2492257 · Received March 13, 2012

Report

Report Number: 2183620-2012-00010
Event Type: Injury
Date Received: March 13, 2012
Manufacturer: SYNOVIS SURGICAL INNOVATIONS
Product Code: DXZ
PMA / PMN Number: K983602
Report Source: Manufacturer report
Reporter Location: WA, US
Reporter Occupation: RISK MANAGER

Narratives

Additional Manufacturer Narrative · 1

NO PRODUCT HAS BEEN RETURNED FOR EVAL. SYNOVIS' VASCU-GUARD PRODUCT IS MANUFACTURED IN A CONTROLLED ENVIRONMENT UNDER STRICT CONTROLS. ALL VASCU-GUARD PRODUCTS MUST UNDERGO 100% STERILITY VERIFICATION AS PART OF OUR MFG PROCESS. THE DEVICE HISTORY RECORD WAS REVIEWED. ACCORDING TO THE DEVICE HISTORY RECORD, THE DEVICE PASSED STERILITY TESTING AND MET ALL SPECIFICATIONS AT THE TIME OF MANUFACTURE. IN ADDITION, A REVIEW OF THE ENVIRONMENTAL MONITORING SYSTEM REVEALED THAT E. COLI HAS NEVER BEEN IDENTIFIED IN THE MFG FACILITY.

Description of Event or Problem · 1

PT HAD A CAROTID ENDARTERECTOMY PROCEDURE WHERE A VASCU-GUARD PATCH WAS IMPLANTED. THE INCISION WAS SEALED WITH DERMABOND, A LIQUID BONDING AGENT, AT THE TIME OF SURGERY. PT WAS DISCHARGED TWO (2) DAYS POST-OP WITHOUT COMPLICATION. PT WAS READMITTED NINE DAYS LATER WITH PAIN AND SWELLING AT THE SURGICAL SITE BUT NO DRAINAGE. THE PT WAS DIAGNOSED WITH E. COLI INFECTION, TREATED WITH 1 GRAM OF CEFTRIAXONE EVERY 24 HOURS AND THE VASCU-GUARD PATCH WAS REMOVED AND REPLACED WITH A SAPHENOUS VEIN GRAFT. THE PT WAS DISCHARGED AND IS RECEIVED AN OUTPATIENT INFUSION OF 1 GRAM CEFTRIAXONE EACH DAY THROUGH (B)(6) 2012.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VASCU-GUARD PERIPHERAL VASCULAR PATCH	VASCULAR PATCH	DXZ	SYNOVIS SURGICAL INNOVATIONS	VG-0108N	5790031-1676787

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR			DERMABOND ADVANCED TOPICAL SKIN ADHESIVE