GORE EXCLUDER AAA ENDOPROSTHESIS

MDR report key: 1952086 · Received January 4, 2011

Report

Report Number: 2017233-2011-00003
Event Type: Injury
Date Received: January 4, 2011
Date of Event: December 8, 2010
Report Date: January 4, 2011
Manufacturer: W.L. GORE & ASSOCIATES
Product Code: MIH
PMA / PMN Number: P020004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SW
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF THE MFG RECORDS FOR THE DEVICE IS BEING CONDUCTED. FURTHER INVESTIGATION IS BEING CONDUCTED.

Description of Event or Problem · 1

ON (B)(6), 2010, THE PHYSICIAN IMPLANTED A GORE EXCLUDER AAA ENDOPROSTHESIS (C3) TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DUE TO TORTUOUS ANATOMY; HOWEVER, THE PHYSICIAN WAS UNABLE TO CANNULATE THE CONTRALATERAL GATE. WHILE ATTEMPTING TO SNARE THE GUIDEWIRE FROM THE IPSILATERAL SIDE, BOTH THE GUIDEWIRE AND SNARE CATHETER GOT STUCK, CAUSING THE PHYSICIAN TO INADVERTENTLY PULL THE DEVICE INTO THE ANEURISMAL SAC. THE PT WAS CONVERTED TO OPEN SURGERY. THE PT TOLERATED THE PROCEDURE AND IS DOING FINE. AS REPORTED TO GORE, THE PHYSICIAN ATTRIBUTED THE DEVICE MOVEMENT TO EXCESSIVE PRESSURE ON THE DEVICE BIFURCATION DURING THE WIRE AND SNARE CATHETER MANIPULATION.

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	7894360

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Hospitalization\| R