FDA Adverse Event Injury Summary report: N

ANEURX STENT GRAFT SYSTEM

MDR report key: 1812622 · Received August 17, 2010

Report

Report Number: 2953200-2010-01569
Event Type: Injury
Date Received: August 17, 2010
Date of Event: July 20, 2010
Report Date: July 20, 2010
Manufacturer: MEDTRONIC CARDIOVASCULAR SANTA ROSA
Product Code: MIH
PMA / PMN Number: P990020
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION RESULTS: (ENDOLEAK), (MODERATE CALCIFICATION, AND AORTIC NECK DISEASE PROGRESSION WITH AORTIC NECK DILATION). CONCLUSIONS: (MODERATE CALCIFICATION, AND AORTIC NECK DISEASE PROGRESSION WITH AORTIC NECK DILATION).

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 SIZE AT THE TIME OF IMPLANT IS UNKNOWN, CURRENTLY THE ANEURYSM IS 6.1 CM IN DIAMETER. VESSEL MORPHOLOGY AT THE TIME OF IMPLANT IS UNKNOWN, CURRENTLY THE VESSEL MORPHOLOGY WAS REPORTED AS MILD TORTUOSITY, MODERATE CALCIFICATION AND AORTIC NECK DISEASE PROGRESSION WITH AORTIC NECK DILATION. IT WAS REPORTED A RECENT CT DEMONSTRATE A TYPE I ENDOLEAK, CAUSED BY DISEASE PROGRESSION WITH AORTIC NECK DILATATION. THE STENT GRAFT REMAINS AT THE RENAL ARTERIES. THE PHYSICIAN IMPLANTED A 32 TALENT CONVERTER UP TO THE SMA. THE PHYSICIAN USED THE SNORKEL-UP TECHNIQUE FROM THE RENAL ARTERIES WITH COVERED STENTS AND PERFORMED A FEMORAL TO FEMORAL BYPASS. THE RENAL ARTERIES ARE PATENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ANEURX STENT GRAFT SYSTEM		MIH	MEDTRONIC CARDIOVASCULAR SANTA ROSA	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	86 YR		Required Intervention