FDA Adverse Event Injury Summary report: N

ANEURX

MDR report key: 2882357 · Received December 20, 2012

Report

Report Number: 2953200-2012-02448
Event Type: Injury
Date Received: December 20, 2012
Date of Event: November 26, 2012
Report Date: November 26, 2012
Manufacturer: MEDTRONIC IRELAND
Product Code: MIH
PMA / PMN Number: P990020
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (MIGRATION, ENDOLEAK). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION, AORTIC NECK ANGULATION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION, AORTIC NECK ANGULATION).

Description of Event or Problem · 1

AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT IS UNKNOWN. CURRENTLY, THE VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS 26 MM IN DIAMETER AT THE RENAL ARTERIES. CURRENTLY, THE STENT GRAFT IS AT THE RENAL ARTERY ON THE LEFT SIDE AND APPROXIMATELY 7 MM BELOW THE RENAL ARTERY ON THE RIGHT SIDE DUE TO ANGULATION OF THE AORTIC NECK, THERE IS DISEASE PROGRESSION, WITH AORTIC NECK DILATATION. NO ENDOLEAK WAS NOTED. IT WAS REPORTED THAT A RECENT CT REVEALED THAT THERE WAS ANEURYSM ENLARGEMENT OF UNKNOWN ETIOLOGY. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT 28 AORTIC CUFF AND THE MIGRATION WAS RESOLVED. THERE IS A TYPE II ENDOLEAK COMING FROM THE ILIO-FEMORAL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ANEURX	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC IRELAND		V00215202

Patients

Seq	Age	Sex	Outcome	Treatment
1	00068 YR		Required Intervention