MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number S-60-150-120-P6

Device Problems Stretched (1601); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)

Patient Problem Embolism (1829)

Event Date 09/11/2020

Event Type  Injury  

Manufacturer Narrative

The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that on (b)(6) 2020, the patient presented with a tight iliac bifurcation and a heavily calcified superficial femoral artery (sfa) lesion.The operator had difficulty accessing the sfa with the guide catheter and unspecified wire due to anatomy.Vessel preparation was performed using a 5.0 plain balloon for 2 minutes and a 6.0 drug eluting balloon for another 2 minutes.Reportedly, the vessel remained heavily calcified following vessel preparation and inadequate vessel preparation was possible.One supera stent delivery system (sds) advanced and stent was successfully implanted, without any unusual resistance or issue.A second supera sds advanced without issue to the treatment sfa site.During stent deployment, resistance was felt with the thumbslide, making it difficult to advance and retract.The operator was able to deploy the stent using the thumbslide although there was this resistance.This stent had slightly elongated due to the difficult deployment, however, it remained implanted at the intended location.The heavily calcified anatomy was thought to be the reason for the difficult deployment.Following, a third supera sds advanced without issue and stent deployed successfully.At the end of the procedure, an embolus was observed in the lower extremities.Tpa was provided as treatment and surgery was considered although not performed.There was no additional adverse patient sequela and the procedure was completed without further issues reported.There was no clinically significant delay.No additional information was provided regarding this issue.

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported deployment difficulty and resistance with the thumbslide was not confirmed.The reported stent elongation was unable to be confirmed as the stent was not returned.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other complaints reported from this lot.The investigation determined that the reported difficulties and subsequent patient effects were likely related to procedural circumstances.Based on the reported information, it is likely that the deployment difficulty and resistance with the thumbslide were the result of anatomical challenges.It is likely that the distal sheath of the delivery system was restricted or bent in the tight iliac bifurcation and heavily calcified lesion causing difficulty advancing the thumbslide resulting in deployment difficulty and stent elongation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10621503
• MDR Text Key: 209632008
• Report Number: 2024168-2020-08228
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211843
• UDI-Public: 08717648211843
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: S-60-150-120-P6
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 0050661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SUPERA STENT; SUPERA STENT
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR