GORE-TEX SUTURE

Report

Report Number: 3003910212-2013-00008
Event Type: Injury
Date Received: April 26, 2013
Date of Event: January 12, 2011
Report Date: March 21, 2013
Manufacturer: W.L. GORE & ASSOCIATES,INC
Product Code: GAW
PMA / PMN Number: P820083
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE CASE REPORT DOES NOT SPECIFY THE NUMBER OF SUTURES INVOLVED IN CREATING THE NEOCHORDAE IN THE INITIAL PROCEDURE. THE AUTHORS HYPOTHESIZE THAT THE SUTURE FAILURE IS LIKELY DUE TO INTRACARDIAC FORCES THAT EXCEED THE STRENGTH OF THE SUTURE RATHER THAN A STRUCTURAL CHANGE OF THE SUTURE LEADING TO A FAILURE. BASED ON THE LIMITED INFORMATION PROVIDED, A ROOT CAUSE HAS NOT BEEN DETERMINED. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING, TRENDING AND FOLLOW-UP. CITATION: MICHAEL H. YAMASHITA, PETER L. SKARSGARD, INTERMEDIATE AND EARLY RUPTURE OF EXPANDED POLYTETRAFLUOROETHYLENE NEOCHORDAE AFTER MITRAL VALVE REPAIR. THE ANNALS OF THORACIC SURGERY 2011:92:341-343.

Description of Event or Problem · 1

A REVIEW OF THE ANNALS OF THORACIC SURGERY, (B)(6) 2011, REVEALED A CASE REPORT ENTITLED, "INTERMEDIATE AND EARLY RUPTURE OF EXPANDED POLYTETRAFLUOROETHYLENE NEOCHORDAE AFTER MITRAL VALVE REPAIR." THIS REPORT DESCRIBES A (B)(6) FEMALE PT WITH SEVERE MITRAL REGURGITATION NECESSITATING MITRAL VALVE REPLACEMENT 14 MONTHS AFTER THE INITIAL REPAIR. THE AUTHORS NOTED THAT THE CV-5 EPTFE NEOCHORDAE (GORE-TEX SUTURE) WERE RUPTURED IN SEVERAL LOCATIONS. THE VALVE REPLACEMENT WAS SUCCESSFUL AND THE PT HAD AN UNEVENTFUL POSTOPERATIVE RECOVERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
181854	GORE-TEX SUTURE	GAW/SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE	GAW	W.L. GORE & ASSOCIATES,INC

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR		Required Intervention