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

Model Number AB46

Device Problem Device Damaged by Another Device (2915)

Patient Problems Death (1802); Rupture (2208); Blood Loss (2597)

Event Date 02/23/2017

Event Type  Death  

Manufacturer Narrative

Film evaluation summary: the exact cause of the reported type iii fabric endoleak and rcia perforation cannot be conclusively determined from the pre-implant 3d recon report provided.Films at implant and films during the secondary intervention were not provided.The pre-implant 3d recon report confirmed that the proximal portion of the right common iliac artery was calcified.It is possible that ballooning the stent graft implanted in a calcified right common iliac artery may have contributed to the tear in the graft fabric and the possible rcia perforation.The exact cause of the reported compression syndrome, dissection in the left external iliac artery, thrombus built-up in the bifurcate main body, and patient death cannot be conclusively determined from the pre-implant 3d recon report provided.The pre-implant 3d recon report did not reveal any obvious characteristics that could explain the cause of the reported events.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.

Event Description

An endurant iis stent graft system was implanted in a patient for the endovascular treatment of a 4.9 cm abdominal aortic aneurysm.It was reported that the main body was implanted from the right and an ipsilateral and contralateral extension were successfully implanted.During post-implant ballooning there was a possible rupture of the right common iliac artery as well as a possible tear in the graft fabric due to calcium.The balloon was inflated between ten and twelve times during the procedure with an unknown fluid under normal evar balloon pressures.The balloon was fully within the stent graft fabric when inflated.The ipsilateral limb was relined but the patient was still unstable.Further imaging revealed a type ia endoleak.Additional ballooning was performed and the procedure was completed.The patient then became unstable in the icu and an open procedure was performed to investigate the iliac rupture.Possible compression syndrome was discovered and relieved.The next day, a ct showed that the left external iliac was dissected and the contralateral limb and main body filled with thrombus.No type ia endoleak was seen.An angiojet and thrombectomy were performed.The left contralateral limb was also relined and a cuff was implanted to push thrombus aside.Another manufacturer's bare metal self-expanding stent was placed to cover the dissection flap in the left external iliac artery.The post angiogram looked successful and showed no thrombus or endoleaks.After the procedure the patient again became unstable and an additional open intervention was performed.The patient expired on the table from unknown causes.The physician also stated that the cause of the event could not be determined.No additional clinical sequelae were reported.

Manufacturer Narrative

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.

Event Description

Additional information received confirmed the following: per the physician's statement the cause of death was related to the ruptured aneurysm and subsequent loss of blood.No additional medical records will be provided.

Manufacturer Narrative

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: paola garnica ; 3576 unocal place; santa rosa, CA 95403 ; 7075661361
• MDR Report Key: 6444002
• MDR Text Key: 71200338
• Report Number: 2953200-2017-00470
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K050038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2018
• Device Model Number: AB46
• Device Catalogue Number: AB46
• Device Lot Number: 0008251638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 60