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 Problem Perforation of Vessels (2135)

Event Date 03/23/2016

Event Type  Death  

Manufacturer Narrative

Conclusions: failure to follow instructions (ballooning of suprarenal struts).Film evaluation results are: a review of pre-implant drawing and ct transverse slice images revealed that the patient had a 5cm max diameter infrarenal aaa.Per the ct and drawing the proximal neck was severely angulated ~90 deg relative to the top of the aaa sac.Extensive aortic calcification was seen near the origin of the celiac artery, and little calcification was seen distal to the renal arteries.The proximal neck diameter was 19mm just below the renal arteries, and near the angulated mid-length portion of the neck the flow lumen diameter narrowed down to ~11mm (l-r).The length of the tortuous neck was 5.5cm, and the diameter near the bottom of the neck was 17mm.The distal aortic diameter measured 26 x 39mm and contained thrombus.The iliac arteries were moderately tortuous.The diameter of the rcia ranged from 17 ¿ 22 ¿ 20mm along the 29mm length, and the diameter of the lcia ranged from 20 ¿ 13mm along the 33mm length.Moderate calcification was seen near the left iliac bifurcation.Review of ct¿s and post-implant drawing same day post-implant revealed that an endurant stent graft system was implanted in the patient.The bifurcate was positioned just below the renals within the severely angulated neck.The suprarenal stents were placed just below the celiac artery.Beginning near the apices of the suprarenal stents, contrast was seen outside the posterior wall of the aorta continuing down to the length of the neck.The bifurcate proximal od measure 23mm, and near the level of the flow divider where the neck was acutely angulated, measured 17mm od.Widespread contrast was also seen within the aaa sac; the source of the endoleak could not be determined.The ipsi limb and extension were placed down into the left common iliac artery, and the contra limb was positioned down into the distal right common iliac artery.The stent graft was patent, and no limb kinks or compression was observed.No other obvious stent graft issues were seen.The exact cause of the aortic perforation could not be determined from the films provided.Films during implant were not available for return, therefore, it is unknown what portion of the procedure the aortic perforation took place.It is possible that delivery and removal of the stent graft delivery system and accessory components into (and out of) the highly angulated proximal neck may have contributed to the perforation.Ballooning may have also contributed.It could not be confirmed (or ruled out) if the suprarenal stents may have also contributed.The exact source and cause of the endoleak(s) seen within the aaa could not be determined.This may have been a proximal type i endoleak likely caused by the angulated neck, but cannot rule out a type ii or type iv endoleak.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 5.1 cm in diameter abdominal aortic aneurysm.Vessel morphology was reported as very fragile and severe aortic neck angulation, (90 degree).It was reported that after the stent grafts were implanted, there was a proximal type ia endoleak.The physician elected to model the stent graft with a reliant balloon.The physician inflated the reliant balloon several times to suprarenal struts.After several balloon inflations the anesthesiologist reported a reduction in the patient¿s blood pressure.An angiography was performed and there was vessel perforation just below renal artery.A balloon was inflated to stabilize the blood pressure and an endurant 23x23x49 was implanted for the treatment.Blood pressure was restored, and the patient was continuously transferred to another room to perform ct scan.The ct revealed that there was still a proximal type i endoleak, due to the vessel perforation.The physician elected to convert to an open abdominal surgery repair.Per the physician the cause of the type i endoleak was anatomy related and the cause of the vessel perforation was user related, balloon modelling of the suprarenal struts.The patient later expired due to loss of blood.

Manufacturer Narrative

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: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 5577556
• MDR Text Key: 42674242
• Report Number: 2953200-2016-00779
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2016
• 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; Required Intervention
• Patient Age: 00085 YR