GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

Report

Report Number: 2017233-2013-00015
Event Type: Injury
Date Received: January 10, 2013
Date of Event: October 17, 2009
Report Date: December 14, 2012
Manufacturer: W.L. GORE & ASSOCAITES
Product Code: DYB
PMA / PMN Number: K032073
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) FOR THE GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE, ENSURE THE VESSEL IS OF ADEQUATE SIZE AND APPROPRIATE TORTUOSITY FOR THE INSERTION OF THE INTRODUCER SHEATH. IF VESSEL IS TOO SMALL, MAJOR BLEEDING, VESSEL RUPTURE/PERFORATION, AND SERIOUS INJURY TO THE PT INCLUDING DEATH MAY RESULT.

Description of Event or Problem · 1

ON (B)(6) 2009, THE PT UNDERWENT ENDOVASCULAR REPAIR FOR A THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE TAG THORACIC ENDOPROSTHESIS. A GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE WAS USED TO ADVANCE THE DEVICE FOR DEPLOYMENT. THE PT TOLERATED THE PROCEDURE. ON (B)(6) 2009, THE PT REQUIRED TRANSFUSION DUE TO BLEEDING FROM THE ACCESS SITE. ONE UNIT OF BLOOD WAS TRANSFUSED. THE BLEEDING SOON RESOLVED AND THE PT'S CONDITION WAS GOOD. ON (B)(6) 2009, THE PT EXPERIENCED THE REDUCED MUSCULAR POWER IN THE LOWER LIMB. THE PHYSICIAN DIAGNOSED SPINAL CORD DISORDER. AN IVH CATHETER WAS INSERTED AND CATECHOLAMINE WAS DELIVERED. THE PT SHOWED GOOD RECOVERY. AT THE PT'S ONE MONTH FOLLOW UP, IT WAS REPORTED THAT THE PT EXHIBITED GOOD SIGNS OF RECOVERY, WITH NO SYMPTOMS OF SPINAL CORD DISORDER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
14934	GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE	DYB/INTRODUCER, CATHETER	DYB	W.L. GORE & ASSOCAITES		06696557

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR		Hospitalization\| O\| R\| S