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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND RELIANT BALLOON CATHETER, PERCUTANEOUS Back to Search Results
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.

 
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Brand NameRELIANT BALLOON
Type of DeviceCATHETER, 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 Key6799823
MDR Text Key82862565
Report Number2953200-2017-01310
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK050038
Number of Events Reported1
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 Received08/17/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2019
Device MODEL NumberREL46
Device Catalogue NumberREL46
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/24/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/31/2017
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
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