FDA Adverse Event Malfunction Summary report: N

GORE EXCLUDER AAA ENDOPROSTHESIS

MDR report key: 2443994 · Received January 16, 2012

Report

Report Number: 2017233-2012-00030
Event Type: Malfunction
Date Received: January 16, 2012
Date of Event: December 21, 2011
Report Date: December 21, 2011
Manufacturer: W.L. GORE & ASSOCIATES
Product Code: MIH
PMA / PMN Number: P020004
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. RESULTS ARE PENDING COMPLETION OF ENGINEERING EVAL.

Description of Event or Problem · 1

ON (B)(6) 2011, THE PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, THE TRUNK AND CONTRALATERAL COMPONENTS WERE SUCCESSFULLY DEPLOYED. HOWEVER, UPON WITHDRAWAL OF THE PXC DELIVERY CATHETER, IT BECAME STUCK AT THE END OF THE INTRODUCER SHEATH. IT WAS REPORTED THE CATHETER AND SHEATH WERE STUCK IN THE LEFT EXTERNAL ILIAC ARTERY (EIA), 3-4 CM DISTAL TO THE EIA/IIA BIFURCATION. THE DIAMETER OF THE EIA WAS REPORTED TO BE 5-7 MM, WITH NO CALCIFICATION OR TORTUOSITY. THE PHYSICIAN ATTEMPTED TO PUSH, PULL AND ROTATE THE DELIVERY CATHETER, BUT STILL COULD NOT CLEAR THE CATHETER PAST THE END OF THE SHEATH. THE PHYSICIAN WAS ABLE TO REMOVE THE PXC DELIVERY CATHETER AND INTRODUCER SHEATH SIMULTANEOUSLY WITHOUT ANY FURTHER COMPLICATION. THE PT TOLERATED THE PROCEDURE. UPON INSPECTION, THE LEADING (DISTAL) OLIVE WAS EXTENDED AND NEARLY SEPARATED. THE CATHETER WILL BE SENT TO GORE FOR EVAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GORE EXCLUDER AAA ENDOPROSTHESIS	MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	W.L. GORE & ASSOCIATES	WLG425	9655904

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR