MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 1012014-150

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion in the moderately calcified, mildly tortuous left distal superficial femoral artery.A 5x150mm absolute pro ll self-expanding stent system (sess) faced resistance with a non-abbott sheath during advancement, and the sess faced resistance with the thumbwheel during stent deployment.The stent was noted to have separated, and the distal portion remained implanted in the lesion.The proximal separated portion of the stent was embedded with an unspecified stent.The sess faced resistance with the same sheath during removal, so slight force was applied.Then, a same sized absolute pro ll sess was being used, but it faced resistance with the sheath during insertion.After removal, the sess shaft was noted to be kinked and felt rough.A non-abbott stent was used in the target lesion with separated stent to successfully complete the procedure.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.

Event Description

N/a.

Manufacturer Narrative

A visual and functional analysis was performed on the returned device.The reported deployment difficulty and resistance with the thumbwheel were confirmed.The difficulty removing and stent separation were unable to be confirmed as the stent was not returned.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 revealed no indication of a lot specific product quality issue.It should be noted that the absolute pro ll instructions for use states: ¿should unusual resistance be felt at any time during lesion or stricture access or delivery system removal, the introducer sheath / guiding catheter and stent system should be removed as a single unit.Applying excessive force to the stent delivery system can potentially result in loss or damage to the stent and delivery system components.¿ in this event, the removal against resistance does not appear to have contributed to the initial deployment difficulty and thumbwheel locking up.The investigation determined the reported difficulties resulting in unexpected medical intervention were likely related to circumstances of the procedure.In this case, it was reported that resistance was encountered during advancement into the non-abbott sheath.It is likely that the sheath was bent or collapsed in the anatomy (possibly at the aortic bifurcation) causing resistance during advancement and preventing movement of the shaft lumens and causing resistance with the thumbwheel.Additionally, it may be possible that force was applied while attempting to rotate the thumbwheel against resistance causing the outer member to separate resulting in the ribbon being displaced within the handle and preventing further deployment as noted on the returned unit.The reported stent separation likely occurred when the delivery system was removed from the anatomy with the stent partially expanded and apposed to the vessel wall.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12699528
• MDR Text Key: 278561896
• Report Number: 2024168-2021-09611
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

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: 05/31/2022
• Device Catalogue Number: 1012014-150
• Device Lot Number: 9062061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/26/2021
• Supplement Dates Manufacturer Received: 11/11/2021
• Supplement Dates FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2019
• 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
• Treatment: TERUMO 6F SHEATH
• Patient Outcome(s): Required Intervention