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

Model Number REL46

Device Problems Material Rupture (1546); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2017

Event Type  malfunction  

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

An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 62.5 x 56 mm diameter abdominal aortic aneurysm.The aortic neck had a smaller diameter portion at the top measuring 25 mm proximally and 27 mm distally.The suprarenal aorta was 19 mm - 23 mm from proximal to distal.It was reported that the physician performed a secondary procedure to correct stent graft infolding and an unknown endoleak.The physician used a reliant balloon and ballooned the stent graft body significantly.The reliant balloon ruptured during either the second or third hard inflation but the post angiogram looked good and showed no sign of a endoleak.Approximately one month later, the patient had another ct scan which revealed a large infolding/guttering along with a proximal type i endoleak.The suprarenal stents looked scrunched which may have caused the fabric to infold/gutter from the top of the stent graft fabric down to the top of the flow divider.Another ct was performed one week later and revealed that the patient has a small type iii fabric endoleak due to a tiny suture tear in the endurant ii bifurcated stent graft.Due to the patient¿s current health status there was no intervention at this time.The physician stated the cause of the stent graft infolding and corresponding endoleak was due to the top of stent the stent graft located in a smaller portion of the aorta where the aorta narrowing caused the stent graft to scrunch and infold/gutter and therefore resulting in a type 1 endoleak.Per the physician, the cause of the type iii fabric endoleak may have been due to ballooning but the exact cause cannot be determined.Per the physician, the cause of the balloon burst may have been due to over inflation.No clinical sequelae were reported and the patient will be monitored by their physician.

Manufacturer Narrative

Film evaluation summary: the exact cause of the bifurcate infolding, leading to the proximal type i endoleak, could not be determined from the films provided.Films prior to and during implant were not available for review.Ct¿s returned from 21 ¿ 31 months post-implant confirmed that the bifurcate had radially infolded, along the entire length of the bifurcate aortic body.The infolding occurred on the lateral-right side extended radially inward up to 16mm.It is most likely that this infolding occurred during the initial implant, possibly caused by implanting too large a bifurcate (36mm) within a small diameter aorta.Ct¿s prior to ballooning revealed that the aortic diameter near the level of the sma, 10mm above the top of the suprarenal stents, measured 23mm and was extensively calcified.Near the level of the lowest right renal the aortic diameter measured 25mm, 10mm lower was 26mm, and 25mm below the right renal near the maximum infolding measured 28mm in diameter.The cause of the balloon rupture could not be determined.Films during ballooning were not provided; this may have been caused by over inflation.The films post-ballooning did not correct the infolding, and the cause of the type iii fabric endoleak could not be determined.This may have been also been caused by balloon over inflation, or due to stent abrasion from the infolding.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.

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: 6583423
• MDR Text Key: 75733217
• Report Number: 2953200-2017-00831
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REL46
• Device Catalogue Number: REL46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 78 YR