MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number 1012532-80

Device Problems Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 04/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Concomitant medical products: guide wire: 180cm 0.035 cook roadrunner; inflation: merit presto; sheath: 7fr boston scientific super sheath.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a restenosed cephalic arch.An 8.0 x 40 mm non-abbott balloon catheter was used for pre-dilatation, and a 10 x 80 mm absolute pro vascular self-expanding stent was implanted.Post-dilatation was performed with a non-abbott balloon catheter, which was inflated at 20 atmospheres.However, there was difficulty in removing the balloon (force was applied), and part of the absolute pro vascular stent became broken and migrated towards a fistula that was inside an aneurysm.Therefore, a 12 x 40 mm non-abbott stent was implanted to embed the broken stent in the vessel.A 10 x 40 mm absolute pro self-expanding stent was then implanted in the lesion where the other part of the 10 x 80 mm absolute pro vascular broken stent was.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: a visual inspection was performed on the returned device.The reported difficulties were unable to be confirmed as the stent was not returned.The absolute pro self-expanding stent system instructions for use (ifu), states: should unusual resistance be felt at any time, including resistance unlocking the handle or thumbwheel rotation, during either lesion access or stent deployment, the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.Failure to follow these instructions could result in failure to deploy, difficulties with deployment, partial stent deployment, or deployment in an unintended location.Additionally, it was reported that the absolute pro was being used to treat a restenosed cephalic arch.The indication for use section of the ifu states: the absolute pro vascular self-expanding stent system is indicated for improving luminal diameter in patients with de novo or restenotic atherosclerotic lesions in the native common iliac artery and native external iliac artery with reference vessel diameters between 4.3 mm and 9.1 mm and lesion lengths up to 90 mm.In this case, circumstances of the procedure appear to have contributed to the difficulties.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation determined that the reported difficulties were due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8591242
• MDR Text Key: 144428518
• Report Number: 2024168-2019-03653
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2019

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 Expiration Date: 03/31/2021
• Device Catalogue Number: 1012532-80
• Device Lot Number: 8040661
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 05/08/2019
• Supplement Dates Manufacturer Received: 05/17/2019
• Supplement Dates FDA Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10 FOR CONCOMITANT MEDICAL DEVICES; SEE H10 FOR CONCOMITANT MEDICAL DEVICES
• Patient Outcome(s): Required Intervention