MAUDE Adverse Event Report: MEDTRONIC IRELAND RELIANT BALLOON CATHETER, PERCUTANEOUS

Model Number REL46

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Ischemia (1942); Renal Failure (2041); Perforation of Vessels (2135); Rupture (2208)

Event Date 07/24/2017

Event Type  Death  

Event Description

An endurant ii stent graft system was implanted in a in a patient for the endovascular treatment of a 57mm diameter abdominal aortic aneurysm. The aortic neck was 25mm in diameter and 34mm in length. It was reported that after the stent graft was implanted there was a type ia endoleak. While inflating the reliant balloon at the level of the renal arteries, the physician over inflated the aorta and caused the aorta to rupture. The physician removed the reliant balloon and placed another manufacturer¿s balloon to occlude the aorta and proceeded to convert the patient to an open procedure. A tube graft was sewn in as well as renal implantation. The renal bypass failed and the patient went on dialysis. The patient then expired due to complications from the open procedure that followed the rupture. The physician stated that the patient developed bowel ischemia and perforated his bowel. Per the physician the cause of the rupture was user error. The cause of the proximal type i endoleak was unknown but the physician noted that the proximal aortic neck area was like tissue paper and that it was difficult to sew the graft to the aorta after the patient was converted to open repair. No additional clinical sequelae were reported.

Manufacturer Narrative

Film evaluation summary: the exact cause of the events could not be determined from the single returned film. A pre-implant sizing worksheet revealed that the patient had a severely angulated proximal neck measuring 25 mm in diameter, which was noted as mildly calcified. A single returned still angiogram image during implant revealed that the endurant bifurcate was positioned ~5 mm below the visible right renal artery, and the infrarenal neck was angulated ~45 deg. Contrast injection from above the level of the suprarenal stents showed a large amount of contrast near the right side of the bifurcate proximal margin, along the outer curvature, coming from a possible aortic perforation. There may also have been a proximal type i endoleak. Additional films during implant, including during the ballooning event, were not returned, and lack of ct¿s could not permit a more complete assessment of the patient¿s anatomy. The angulated and calcified neck may have contributed to the proximal type i endoleak. It is likely that the reported over ballooning within the diseased and angulated neck, may have led to the aortic rupture. Per the physician¿s assessment the patient expired due to complications from the open procedure that followed the aortic perforation. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

• Brand Name: RELIANT BALLOON
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: ibrahim ibrahim ; 3576 unocal place; santa rosa, CA 95403 ; 7075917650
• MDR Report Key: 6799823
• MDR Text Key: 82862565
• Report Number: 2953200-2017-01310
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K050038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/24/2017

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/17/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 03/31/2019
• Device MODEL Number: REL46
• Device Catalogue Number: REL46
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 03/31/2017
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 08/17/2017 Patient Sequence Number: 1