ENDURANT

Report

Report Number: 2953200-2013-01172
Event Type: Injury
Date Received: June 21, 2013
Date of Event: May 26, 2013
Report Date: May 26, 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); LACK OF INFORMATION (UNKNOWN CAUSE OF ENDOLEAK).

Description of Event or Problem · 1

AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT INITIALLY THE PHYSICIAN SUSPECTED THERE WAS A TYPE III OR IV ENDOLEAK SOMETIME POST IMPLANT; HOWEVER, THE PHYSICIAN LATER CONFIRMED THAT THE ENDOLEAK WAS A TYPE II. FURTHER INFORMATION WAS PROVIDED STATING THAT THE PHYSICIAN PLANNED TO PERFORM INTERVENTION AS THERE WAS A TYPE II OR TYPE III ENDOLEAK. APPROXIMATELY FIVE WEEKS POST IMPLANT COILING OF THE IMA WAS PERFORMED AFTER WHICH A CT WAS PERFORMED AND SHOWED THE ENDOLEAK WAS COMING FROM A JUNCTION SITE OF THE LIMB AND NOT FROM THE IMA. THE DECISION WAS MADE TO MONITOR THE PATIENT AT THIS TIME. ONE WEEK LATER INTERVENTION WAS PERFORMED WHERE BALLOONING OF THE IPSILATERAL AND CONTRALATERAL LIMBS WAS PERFORMED. STILL THE PHYSICIAN COULD NOT DETERMINE WHETHER THIS WAS A TYPE II OR TYPE III ENDOLEAK. THE DECISION WAS MADE TO IMPLANT AN ENDURANT (B)(4) LIMB ON THE RIGHT SIDE AT THE JUNCTION BETWEEN THE CONTRALATERAL GATE AND LIMB AS THERE WAS SUSPECT OF A JUNCTIONAL TYPE III ENDOLEAK. THE PATIENT IS BEING MONITORED. THE CAUSE OF THE ENDOLEAK IS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
282611	ENDURANT	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC IRELAND		V01725002

Patients

Seq	Age	Sex	Outcome	Treatment
1	00084 YR		Required Intervention