FDA Adverse Event Injury Summary report: N

ENDURANT

MDR report key: 3083349 · Received April 29, 2013

Report

Report Number: 2953200-2013-00802
Event Type: Injury
Date Received: April 29, 2013
Date of Event: January 1, 2012
Report Date: April 1, 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; AORTA NECK ANGULATION WAS 60 DEGREE). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; AORTA NECK ANGULATION WAS 60 DEGREE).

Description of Event or Problem · 1

AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT IS UNKNOWN. CURRENTLY IT WAS REPORTED THAT THE AORTA NECK ANGULATION WAS 60 DEGREES. THE PROXIMAL AORTIC NECK IS 20 - 21MM IN DIAMETER AND 20MM IN LENGTH. IT WAS REPORTED THAT A CT REVEALED A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT AORTIC CUFF TO TREAT THE PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN STATED THAT THE PLACEMENT/IMPLANTATION OF THE ENDURANT AORTIC CUFF WAS INACCURATE (LOWER THAN INTENDED) THEREFORE THE PROXIMAL TYPE I ENDOLEAK DID NOT RESOLVE. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER MANUFACTURER'S STENT GRAFT PROXIMAL TO THE ENDURANT AORTIC CUFF AND THE PROXIMAL TYPE I ENDOLEAK RESOLVED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
185546	ENDURANT	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC IRELAND

Patients

Seq	Age	Sex	Outcome	Treatment
1	00073 YR		Required Intervention