MAUDE Adverse Event Report: MEDTRONIC IRELAND ASSURANT COBALT; STENT, ILIAC

Catalog Number UNK-CV-GWY-ASS-COB

Device Problems Difficult to Remove (1528); Physical Resistance (2578); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During an index procedure for treatment of an aneurysm the physician inserted a 6fr parent guiding catheter and a non-medtronic 5mm stent from the left arm.Preparation was made for the chimney technique in the right renal artery(ra).Via the right femoral artery (fa), a non-medtronic 6mm stent was delivered up through a 6-fr non-medtronic guiding sheath, and preparation was made for the chimney technique in the left ra.On the right side, through an 18-fr non-medtronic sheath, a stiff wire, 5-fr sheath, an angiographic catheter, and a steering catheter were also inserted altogether.The steering catheter was left inside the aneurysm and the endurant stent graft was implanted via left access.Two non-medtronic stents were also deployed through distal and proximal access at this point.A touch-up was performed using the kissing technique, and through the catheter in the aneurysm, a non-medtronic idc coil was packed in the aneurysm.An assurant cobalt device was then selected (6mmx3cm) to reinforce the radial force.The assurant cobalt was implanted inside the non-medtronic stent previously deployed in the right ra and a non-medtronic balloon expandable stent was implanted inside the non-medtronic stent previously deployed in the left ra as part of the original treatment plan.When the physician attempted to withdraw the assurant cobalt delivery system post-deployment, it was reported that the balloon of the delivery system was caught on the anchor pins of the endurant¿s suprarenal stent.As per a proven technique, as soon as the inflated balloon was deflated, the assurant cobalt delivery was retracted to near the left subclavian artery(lsca).No endoleaks were observed on final angiography.It was reported that during withdrawal of the sheath from the left arm for removal of the assurant cobalt delivery system, resistance was noted.When the physician pulled out the delivery system only, a tearing sound was heard, and the balloon tip was missing.Checking inside the sheath, the radiopaque marker at the tip was retrieved.The balloon was ruptured.Angiography was performed to check from the lsca to the upper arm, elbow, and down to the wrist.No foreign material was found.No foreign material was found by directly checking the vessels.It was reported that all the balloon fragments were found inside the sheath, and should any balloon fragment remain in the body, its¿ size would need to be about 1mm.No further patient treatment was required.

• Brand Name: ASSURANT COBALT
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7620364
• MDR Text Key: 111707801
• Report Number: 9612164-2018-01503
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110011
• 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
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-GWY-ASS-COB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2018
• 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: 68 YR