GORE EXCLUDER AAA ENDOPROSTHESIS

MDR report key: 1180092 · Received September 29, 2008

Report

Report Number: 2017233-2008-00672
Event Type: Injury
Date Received: September 29, 2008
Date of Event: September 5, 2008
Report Date: September 26, 2008
Manufacturer: W.L. GORE & ASSOCIATES
Product Code: MIH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED.

Description of Event or Problem · 1

IN 2008, THIS PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. A TYPE I ENDOLEAK WAS OBSERVED AT DISTAL ENDS OF BOTH THE RIGHT AND LEFT LEG DEVICES. AN ILIAC EXTENDER COMPONENT WAS IMPLANTED IN THE LEFT LEG AND A CONTRALATERAL LEG COMPONENT WAS IMPLANTED IN THE RIGHT LEG, EXTENDING THE EXISTING DEVICES. THE TYPE I ENDOLEAK IN THE RIGHT LEG WAS RESOLVED. THE TYPE I ENDOLEAK IN THE LEFT LEG PERSISTED. THE PHYSICIAN IMPLANTED A PALMAZ STENT AT THE DISTAL END OF THE LEFT ILIAC EXTENDER COMPONENT. THE TYPE I ENDOLEAK PERSISTED. THE PHYSICIAN CHOSE TO END THE PROCEDURE BELIEVING THE ENDOLEAK WOULD RESOLVE ITSELF. A FEW DAYS LATER, A CT IMAGE REVEALED THAT THE TYPE I ENDOLEAK WAS PERSISTING. ON THE FOLLOWING MONTH, A REINTERVENTION OCCURRED WHERE THE LEFT INTERNAL ILIAC WAS COIL EMBOLIZED PRE-PROCEDURE AND AN ILIAC EXTENDER COMPONENT WAS IMPLANTED, EXTENDING THE EXISTING DEVICE IN THE LCI. THE TYPE 1 ENDOLEAK WAS RESOLVED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GORE EXCLUDER AAA ENDOPROSTHESIS	NONE	MIH	W.L. GORE & ASSOCIATES	WLG325	05959525

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Required Intervention