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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 AB46
Device Problems Material Rupture (1546); Device Damaged by Another Device (2915)
Patient Problem Death (1802)
Event Date 03/20/2018
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
An endurant ii aortic extension was implanted in another manufacturer's stent graft system for the treatment of a type ia endoleak. The primary stent graft was implanted on an unknown date approximately 5 years earlier for the treatment of a 95mm abdominal aortic aneurysm. It was reported during the index procedure the physician elected to perform chevar. The implantation of the aortic extension and left and right renal stents was successful. During simultaneous ballooning of both non-medtronic balloon expandable stents with a reliant balloon, the reliant and both non-medtronic balloons burst. The physician recovered the left burst balloon with no problems. During the recovery of the right balloon the physician maneuverer the sheath wide and over the peak of the bare spring at the level of the suprarenal stents however the sheath became caught in one of the stents and it was not possible to withdraw the sheath and balloon. The procedure was converted to open surgery and the patient died post-surgery. The cause of the event is undetermined. No additional clinical sequelae were reported.
 
Manufacturer Narrative
Additional information received reported that it was noted that the neither the left balloon that was recovered or the right balloon that it was not possible to withdraw were reliant balloons but the advanta balloons. Film evaluation summary: from the photograph¿s provided, the cause of the balloon burst leading to the sheath becoming caught on the suprarenal stents and inability to remove the burst balloon and sheath, with the resulting patient death following open repair, could not be determined. Pre-implant films and images during implant showing these events were not available for return, and the explanted device was not returned. Other than a likely lengthwise excision cut seen along the entire length of the stent graft likely occurring during the open repair, no obvious stent graft integrity issues were observed from the two photographs of the explanted aortic cuff that could explain the reported event. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information was received on 08-apr-2018, not 09-apr-2018 as previously reported. 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
alison sweeney
parkmore business park west
galway 
091708096
MDR Report Key7406125
MDR Text Key104653822
Report Number2953200-2018-00520
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K050038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/08/2020
Device Model NumberAB46
Device Catalogue NumberAB46
Device Lot Number0008987950
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2018
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: 04/09/2018 Patient Sequence Number: 1
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