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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.
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Manufacturer (Section D)
parkmore business park west
Manufacturer (Section G)
parkmore business park west
Manufacturer Contact
alison sweeney
parkmore business park west
MDR Report Key7897231
MDR Text Key120968229
Report Number2953200-2018-01330
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberREL46J
Device Catalogue NumberREL46J
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2018
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 Treatment Data
Date Received: 09/21/2018 Patient Sequence Number: 1