MAUDE Adverse Event Report: MEDTRONIC IRELAND RELIANT STENT GRAFT BALLOON CATHETER -OUS; CATHETER, PERCUTANEOUS

Model Number REL46J

Device Problem Device Damaged by Another Device (2915)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Hypovolemic Shock (1917); Rupture (2208)

Event Date 08/29/2018

Event Type  Death  

Manufacturer Narrative

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 55mm diameter abdominal aortic aneurysm.Severe tortuosity and severe calcification was reported in the patient.It was reported that during the index procedure it was difficult to remove the delivery system after device implantation as the spindle was stuck to the suprarenal stent.The spindle was not recaptured as the suprarenal stent was in a narrow aorta where recapture was impossible.When the narrowed part of aorta at the bare stents below the renal artery was dilated with a balloon to remove the delivery system, the aorta ruptured and open conversion was performed.It was reported that the physician found it difficult to find and restore rupture points and the access route with severe calcification was damaged; hence it took time to restore.Although the patient left the operation room, the patient expired from hemorrhagic shock in icu.Per the physician, the cause of the event is due to severe tortuosity and severe calcification.It was noted that there was bad calcification in the ruptured part of the aorta.It was also reported the case was outside ifu.No additional clinical sequelae were reported and the patient has expired.

Manufacturer Narrative

Film evaluation summary: the exact cause of the reported events could not be determined from the single film provided.Pre-implant ct¿s were not available so a complete assessment of the patient¿s anatomy could not be performed, and additional images during implant were also not provided.Review of a pre-implant 2-d drawing revealed that the patient had a severely tortuous infrarenal neck with extreme ranges in neck diameter.The neck diameter just below the renal arteries was noted as 29 x 25mm, and along the initial 12mm length the neck severely narrowed down to 11 x 10mm.At this severe narrowing the neck was acutely angulated ~90 deg rt, and distal to this angulated portion along a 45mm length the aneurysmal ¿neck¿ diameter ranged from 30 ¿ 24mm in diameter.At the distal 24mm diameter narrowed location the neck angulated ~120deg lt; relative to the distal aorta.The amount of any angulation in the a-p axis could not be assessed.A single still angiogram during implant was returned.The films were non-contrast with no visible scale; therefore, no assessment of any endoleak or stent graft/vessel patency could be performed, and no stent graft or vessel measurements could be performed.The film revealed that the endurant iis bifurcate had been implanted; the location of the bifurcate relative to the renal arteries could not be confirmed due to lack of contrast.The bifurcate ipsi limb and contra gate had fully deployed and appeared properly expanded; however, there was lack of complete expansion of the suprarenal stents.The apices of the suprarenal stents were seen in close proximity with the delivery system spindle, and 1 or more of suprarenal stents may have been entangled with each other and/or with the spindle.The tapered tip had not been recaptured and was seen positioned ~10mm above the spindle.No clear issues with either the tip or spindle were observed.A balloon (deflated) was seen having been brought up the contra gate and was positioned across the level of the ¿stuck¿ spindle.The bifurcate aortic body was angulated ~90 deg to the bifurcate delivery system stent stop which was positioned just distal to the end of the bifurcate ipsilateral limb.No other clear stent graft issues were observed.The exact cause of the spindle getting caught on the bifurcate suprarenal stents, leading to the inability to remove the delivery system, which then resulted in aortic rupturing during ballooning to try and free the stuck d-s followed by the patient expiring due to hemorrhagic shock, could not be determined from the single non-contrast returned film.Images during stent graft deployment, d-s removal attempts, and ballooning were not provided.However, it appears likely that implanting in the patient¿s challenging (off label) neck, which was highly tortuous, extremely varied in diameter, and also reported as calcified, all likely contributed to the events.It is also likely that procedural issues (likely in conjunction with the anatomy) by not recombining the spindle with the tip (not following the ifu), and possible over-ballooning within the tortuous and calcified neck were all factors that led to spindle becoming stuck on the suprarenal stents and the eventual aortic rupture.A device issue cannot be ruled out as a potential contributor.However, the delivery system was not returned and a product investigation could not be performed.No obvious delivery system issues were seen from the single returned angiogram.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RELIANT STENT GRAFT BALLOON CATHETER -OUS
• 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: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7897231
• MDR Text Key: 120968229
• Report Number: 2953200-2018-01330
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140036
• 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
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REL46J
• Device Catalogue Number: REL46J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2018
• Initial Date FDA Received: 09/21/2018
• Supplement Dates Manufacturer Received: 10/12/2018
• Supplement Dates FDA Received: 11/06/2018
• 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): Death; Required Intervention
• Patient Age: 90 YR
• Patient Weight: 35