ENDURANT

Report

Report Number: 2953200-2013-01241
Event Type: Injury
Date Received: July 2, 2013
Date of Event: May 31, 2013
Report Date: November 19, 2013
Manufacturer: MEDTRONIC IRELAND
Product Code: MIH
PMA / PMN Number: P100021
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); (UNKNOWN CAUSE OF EVENT) CONCLUSIONS: INHERENT RISK OF A PROCEDURE (ENDOLEAK); (UNKNOWN CAUSE OF EVENT).

Description of Event or Problem · 1

IT WAS REPORTED THAT AFTER COMPLETION OF THE INTERVENTION, THE CUFF HAD NOT RESOLVED THE DISTAL TYPE I ENDOLEAK. THE PHYSICIAN USED 2 ENDURANT ILIAC EXTENSIONS. AFTER THE SECONDARY INTERVENTION AN ENDOLEAK, UNKNOWN WAS NOTED AND LEFT UNCORRECTED. A CT WITH CONTRAST WAS DONE RECENTLY AND THE ANEURYSM IS CURRENTLY 64 MM IN DIAMETER.

Description of Event or Problem · 1

AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 65 MM IN DIAMETER FUSIFORM ABDOMINAL AORTIC ANEURYSM WITH AN INFRA-RENAL ANGLE OF 3 DEGREES. PROXIMAL AORTA WAS 28 MM IN DIAMETER AND 24 MM IN LENGTH. DISTAL AORTA WAS 43 MM IN DIAMETER. RIGHT ILIAC ARTERY WAS 18 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 16 MM IN DIAMETER. THE RIGHT AND LEFT FEMORAL ARTERIES WERE 9 MM IN DIAMETER. THE RIGHT ILIAC ARTERY WAS SEVERELY TORTUOUS. THE LEFT ILIAC ARTERY WAS MODERATELY TORTUOUS. THE CIRCUMFERENTIAL AORTIC MURAL THROMBUS/CALCIFICATION AT THE PROXIMAL NECK WAS 10%. IT WAS REPORTED THAT A RECENT CT NOTED THAT THE ANEURYSM WAS 67 MM IN DIAMETER. A TECHNICAL OBSERVATION SHOWED EVIDENCE OF AN UNKNOWN ENDOLEAK. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
302460	ENDURANT	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC IRELAND		V00347855

Patients

Seq	Age	Sex	Outcome	Treatment
1	00072 YR