FDA Adverse Event Injury Summary report: N

ENDURANT ABDOMINAL STENT GRAFT SYSTEM

MDR report key: 2944052 · Received February 5, 2013

Report

Report Number: 2953200-2013-00201
Event Type: Injury
Date Received: February 5, 2013
Date of Event: January 13, 2013
Report Date: January 13, 2013
Manufacturer: MEDTRONIC IRELAND
Product Code: MIH
PMA / PMN Number: P100021
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4), RESULTS: INHERENT RISK OF PROCEDURE (SURGICAL CONVERSION), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVELY RUPTURED ANEURYSM), UNAPPROVED USE OF DEVICE (STENT GRAFT WAS USED FOR TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY RUPTURED ANEURYSM). CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVELY RUPTURED ANEURYSM), USER ERROR CONTRIBUTED TO EVENT (STENT GRAFT WAS USED FOR TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY RUPTURED ANEURYSM).

Description of Event or Problem · 1

AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A PATIENT WITH AN 8 CM DIAMETER PRE-OPERATIVELY RUPTURED ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. VESSEL MORPHOLOGY IS UNKNOWN. THE DECISION WAS MADE TO IMPLANT AN ENDURANT BIFURCATED STENT GRAFT AND THE STENT GRAFT WAS PARTIALLY DEPLOYED; HOWEVER, THERE WAS DIFFICULTY CANNULATING THE GATE DUE TO THE SIZE OF THE ANEURYSM. THE PATIENT WAS LOSING TOO MUCH BLOOD AND THE BLOOD PRESSURE HAD DROPPED. AT THIS POINT THE PHYSICIAN DECIDED TO CONVERT THE PATIENT TO OPEN REPAIR AND EXPLANTED THE STENT GRAFT. NO CLINICAL SEQUELAE WERE REPORTED THE PATIENT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
48971	ENDURANT ABDOMINAL STENT GRAFT SYSTEM	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC IRELAND		V01000642

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention