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

Catalog Number 42055100-120

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Defective Device (2588); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.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 to treat a mildly tortuous, moderately calcified superficial artery that had restenosed.A command es wire was crossed and a 5x100mm armada 35 balloon was advanced to the lesion to pre-dilatation.Then a 5.5x100mm supera stent was advanced to the lesion and deployment was initiated.However, during deployment, it was noted that the stent implant only deployed partially at first.After multiple attempts, the stent deployed completely, however the stent implant was noted as compressed and did not cover the entire target lesion as planned.The delivery system was not removed under fluoroscopy.Another 5.5x80mm supera was used to successfully complete the procedure and cover the entirety of the target lesion.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported difficult or delayed activation was unable to be confirmed due to the condition of the returned device.The reported defective device shortened was 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 identified no other incidents from this lot.Reportedly, the delivery system was not removed under fluoroscopy.It should be noted that the supera peripheral stent system instructions for use states: under fluoroscopy, remove the device from the guide wire and evaluate the improved luminal quality of the treated area.The deviation of the ifu does not appear to have caused/contributed to the reported difficulties.It is possible that during stent deployment interaction with the mildly tortuous and moderately calcified anatomy and/or other devices resulted in the ratchet being unable to properly engage/fully deploy the stent; thus resulting in reported difficult or delayed activation; however this cannot be confirmed.Additionally, it is possible that the delivery system was slightly pushed distally as the stent was being deployed resulting in the reported defective device shortened/compressed stent; however, this could not be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.H6, code 2976 removed.

• 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
• 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: 14946836
• MDR Text Key: 295965476
• Report Number: 2024168-2022-07310
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 42055100-120
• Device Lot Number: 2020761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2022
• 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: 7F, 40CM SHEATH.