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

Catalog Number S-45-060-120-P6

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

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

Event Date 11/09/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Medwatch report # mw5148102.

Event Description

User facility medwatch report (mw5148102) received stating: abbott supera stent delivery device was inserted over the wire and was unable to cross the lesion.The device was removed.Cardiologist noticed a piece of the delivery system missing and the stent was off the delivery device.The missing piece was snared and retrieved.Additional information received from the site: the vessel treated was the distal left popliteal artery that is severely diseased at 90-95%.There was resistance during advancement and failed to cross due to the anatomy.Nothing remains in the patient.There was no clinically significant delay in the procedure.

Manufacturer Narrative

Medical device problem code 2017 - against resistance the device was not returned for analysis.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, force was applied in attempts to advance the device.It should be noted that the supera peripheral stent system instructions for use states: precaution: should unusual resistance be felt at any time during stent system advancement or stent deployment the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement resistance was met with the 90-95% severely diseased anatomy resulting in the reported failure to advance.Interaction/manipulation of the device using force and/or inadvertent mishandling ultimately resulted in the reported material separation and the reported device dislodged or dislocated.The treatment appears to be related to the operational context of the procedure as reportedly the missing piece was snared and retrieved.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 18401390
• MDR Text Key: 331428521
• Report Number: 2024168-2023-14493
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648225949
• UDI-Public: 08717648225949
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S-45-060-120-P6
• Device Lot Number: 2101962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 59 KG