FDA Adverse Event Injury Summary report: N

ENDURANT

MDR report key: 3160209 · Received June 10, 2013

Report

Report Number: 2953200-2013-01092
Event Type: Injury
Date Received: June 10, 2013
Date of Event: May 16, 2013
Report Date: May 16, 2013
Manufacturer: MEDTRONIC IRELAND
Product Code: MIH
PMA / PMN Number: P100021
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; NECK CONTAINED THROMBUS, AND WAS CONICAL SHAPED). CONCLUSION: INHERENT RISK OF A PROCEDURE (ENDOLEAK); DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; NECK CONTAINED THROMBUS, AND WAS CONICAL SHAPED.)

Description of Event or Problem · 1

AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60X56 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK WAS 25 MM IN DIAMETER. THE PATIENT HAD THROMBUS IN THE PROXIMAL NECK. IT WAS REPORTED THAT INT RA-OPERATIVELY, A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. THE PHYSICIAN IMPLANTED AN ENDURANT CUFF JUST BELOW THE RENAL ARTERIES, HOWEVER, THE ENDOLEAK DID NOT RESOLVE. THE PHYSICIAN THOUGHT THE LEAK WOULD SELF-RESOLVE AND FINISHED THE PROCEDURE. THE PATIENT WILL BE MONITORED BY THE PHYSICIAN. THE PHYSICIAN STATED THERE WAS THE POSSIBILITY THAT THE PROXIMAL SEALING WAS NOT STABLE DUE TO THROMBUS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. A REVIEW OF CASE DRAWING SHOWED A CONICAL NECK (21-29MM DIAMETER), WHICH WAS MODERATELY ANGULATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
260222	ENDURANT	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC IRELAND		V02417595

Patients

Seq	Age	Sex	Outcome	Treatment
1	00071 YR