FDA Adverse Event Injury Summary report: N

ENDURANT

MDR report key: 3041543 · Received April 8, 2013

Report

Report Number: 2953200-2013-00644
Event Type: Injury
Date Received: April 8, 2013
Date of Event: March 14, 2013
Report Date: March 14, 2013
Manufacturer: MEDTRONIC IRELAND
Product Code: MIH
PMA / PMN Number: P100021
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, MIGRATION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION; ILIAC DILATATION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION.

Description of Event or Problem · 1

AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM APPROXIMATELY FOURTEEN MONTHS AGO. IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR A TYPE IB ENDOLEAK. THE TYPE IB ENDOLEAK WAS FROM BOTH RIGHT AND LEFT COMMON ILIAC ARTERIES. THERE WAS NO PROXIMAL ENDOLEAK. THE PATIENT'S RIGHT ILIAC HAD DILATED AND THE GRAFT APPEARED TO HAVE PULLED UP INTO A LARGER PART OF THE ILIAC. THE PHYSICIAN EXTENDED WITH A 16X24X156 FROM THE FLOW DIVIDER DOWN TO THE RIGHT HYPOGASTRIC ARTERY TO SEAL JUST OVER 2 CM. THE LEFT COMMON ILIAC HAD DILATED TO OVER 3 CM IN DIAMETER. THE PHYSICIAN PLUGGED THE LEFT HYPOGASTRIC ARTERY AND EXTENDED INTO THE LEFT EXTERNAL WITH A 16X13X199 AND A 13X13X82. THE PATIENT'S ABDOMINAL AORTIC ANEURYSM HAD ENLARGED, BUT WAS ASYMPTOMATIC. THE ENDOLEAKS RESOLVED POST PROCEDURE AND THE PATIENT IS FINE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
143986	ENDURANT	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC IRELAND		V00897841

Patients

Seq	Age	Sex	Outcome	Treatment
1	00076 YR		Required Intervention