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

Model Number REL46

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 03/17/2017

Event Type  Death  

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 and a 2.5 cm in diameter right iliac aneurysm.Vessel morphology was reported as severe calcification in the vessels.It was reported that the right and left common femoral arteries were exposed and controlled secured with a vessel loops.Using an 18gauge needle to gain access into the right common femoral vascular anatomy.Another manufacturer¿s 7fr sheath was placed and a glide wire with another manufacturer¿s catheter were advanced to the suprarenal aorta.The glide wire was exchanged for another guide wire.The catheter and sheath were removed and a sentrant 12fr sheath was advanced to the external artery.The sentrant 12fr sheath was unable to be advanced into the right common iliac due to the calcium.Another manufacturer¿s dilator was used to dilate the common and external iliac arteries.Post dilatation the physician attempted to advance the sentrant 12fr sheath again without success.The physician elected to access the left common femoral artery.A 18ga needle was used along with sentrant 16fr sheath was used to gain access into the vascular anatomy.The sentrant 16fr sheath was unable to be advanced through the right common iliac.Using several dilators and mineral spirits an 18 dilator was placed through the common iliac artery.The endurant bifurcate was placed through the common iliac artery into the infrarenal aorta.The reason the physician placed the bifurcated graft first before he had complete access on the right because if he was unable to advance the bifurcated graft then the patient would be unable to have a evar.The physician directed their attention back to the right iliac artery.Using a series of dilators and ending with a 10x4 balloon; a sentrant 14fr sheath could only be advanced to the level of the right hypogastric.The physician implanted an endurant 13x13x82 iliac limb across the lesion and used another manufacturer¿s balloon to disrupt the calcium.The balloon was removed and an angiogram was performed of the right common iliac, through the sheath.This angiogram revealed that the iliac aneurysm had ruptured.The physician implanted another endurant 13x13x82 iliac limb to cover the ruptured aneurysm.Another angiogram was performed showing a larger external iliac artery perforation.A reliant balloon was placed into the proximal endurant 13x13x82 and inflated with a stop cock occluding inflow to the common iliac artery.The physician performed an emergency cut down over the right external iliac artery and simultaneously the patient¿s blood pressure would not register and cpr was performed for several minutes.The physician could control the perforation by placing clamps on the right external, common and hypogastric arteries.The patient could be revived and the surgery paused for several minutes to allow the patient to recover from losing blood.When the crna felt that the patient was stable enough to proceed; the endurant bifurcate was removed and replaced with a endurant aui.The proximal edge of the endurant aui was advanced to l2.The reliant located on the right was deflated and replaced with another manufacturer¿s catheter.The guide wire was removed and the catheter was connected to a power injector.An angiogram of the aorta was performed and the endurant aui stent graft was placed distal to the lowest left renal artery.The delivery system was removed with no issue and replaced with a sentrant 16fr sheath.From the right; the other manufacturer¿s catheter was removed and replaced with a reliant balloon catheter and advanced to the proximal endurant 13x13x82, inflated to occluded any possible inflow into the right common iliac artery.Contrast was used to perform a left common iliac artery angiogram.An endurant 16x13x93 iliac limb was implanted proximal to the left hypogastric artery.The delivery system was removed and replaced with another reliant balloon.The proximal edge of the aui was ballooned with the reliant.The guide wire on the right was pulled distal to the proximal landing zone and the reliant was re-inflated at the proximal edge.The left common iliac endurant limb was completely ballooned to the wall of the common iliac.The reliant was replaced with another manufacturer¿s catheter and a post stent graft angiogram was performed.The angiogram showed adequate blood flow to the left external and internal iliac arteries.The guide wire and sentrant 16fr sheath were removed from the right common femoral artery.Wanting to restore blood flow to the left lower extremity and take pressure off the heart the right common iliac artery was repaired with and endarterectomy and patch graft.This was performed with no complications.The right retroperitoneal was re-accessed and the right hypogastric was ligated with clips and o-silk.The right common iliac artery was ligated using a vascular clips and o-silk.This was performed with no issues.The right common femoral device was removed and the right common femoral artery was repaired.The physician decided that it was an appropriate time to close the right retroperitoneal exposure/ cut down.The right fem-fem anastomose was secured and bypass graft showed mild back flow.The left common femoral patch graft was opened with an 11 blade and another manufacturer¿s embolectomy balloon catheter was placed in the sfa, however the balloon popped due to calcium.Next a series of another manufacturer¿s embolectomy dilators were used and resulted in a dissection of the right sfa.The left fem-fem anastomose was attached and proper blood flow shown through the graft.The physician performed a right and possibly a left fem-pop along with closing of the cut downs.The patient died of a myocardial infarction five days after the implant procedure.The physician stated that the cause event was related to the patient¿s anatomy, calcification in the right external iliac artery.The physician believed that the myocardial infarction and death were related to the extensive index procedure.According to the physician, the patient did well post index procedure but their heart gave out five days post index procedure.No additional clinical sequelae were reported.

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: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 6491939
• MDR Text Key: 72776384
• Report Number: 2953200-2017-00592
• 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
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: REL46
• Device Catalogue Number: REL46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2017
• 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: 72 YR