ENDURANT II

MDR report key: 3771335 · Received April 24, 2014

Report

Report Number: 2953200-2014-00824
Event Type: Injury
Date Received: April 24, 2014
Date of Event: March 31, 2014
Report Date: March 31, 2014
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). UNDERSIZED STENT GRAFT WAS USED. STENT GRAFT WAS IMPLANTED IN A PATIENT WITH A PRE-IMPLANT DISSECTION.

Description of Event or Problem · 1

AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. SIZING WAS PERFORMED TWO WEEKS PRIOR TO IMPLANT AND THE DISEASE PROGRESSED DURING THIS TIME. IT WAS REPORTED THAT WHEN THE STENT GRAFT WAS IMPLANTED THERE WAS A TYPE IA ENDOLEAK. THE PHYSICIAN DID NOT NOTICE THAT FACT AND WHEN THE STENT GRAFT WAS IMPLANTED IT WAS UNDERSIZED. THE PROXIMAL NECK DIAMETER WAS SIGNIFICANTLY ENLARGED DUE TO AN EXACERBATED ANEURYSM FROM A RETROGRADE DISSECTION. ANOTHER MANUFACTURER¿S AORTIC 28.5X33MM EXTENSION WAS ADDED, HOWEVER, THE TYPE IA ENDOLEAK PERSISTED. NO FURTHER INTERVENTION WAS PERFORMED AND THE DECISION WAS MADE TO MONITOR THE PATIENT. THE PHYSICIAN COMMENTED THAT SINCE THE PATIENT HAS POOR RENAL FUNCTION, IT IS NOT POSSIBLE TO INCREASE THE NUMBER OF ANGIOGRAPHY. JUST BELOW RENAL ARTERY THERE IS A DISSECTION AND EXACERBATED ANEURYSM THEREFORE THE DECISION WAS MADE TO MONITOR THE PATIENT IN ORDER TO AVOID EXACERBATION OF THE PATIENT¿S ANATOMY WITH FURTHER TREATMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
249401	ENDURANT II	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC IRELAND		V04154916

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention