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

Model Number S-60-100-120-P6

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/04/2022

Event Type  Injury  

Manufacturer Narrative

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.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during deployment the stent inadvertently partially deployed in the sheath resulting in the reported difficult or delayed activation and the reported difficult to remove.Interaction of devices/manipulation using force resulted in the reported tip material separation.The treatment(s) appears to be related to the operational context of the procedure as reportedly two snares were attempted and other balloon techniques, but the tip could not be removed.The tip was able to be dragged to the left common femoral via the left groin access and the tip was embedded to the vessel with an additional stent.There was a 2+ hour delay in the procedure but this did not cause harm to the patient.Reportedly, the physician pulled hard when some resistance was noted during removal and the tip separated.It should be noted that the supera peripheral stent system instructions for use states: should unusual resistance be felt at any time during stent system removal, the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.Although it was noted the physician pulled hard in the attempt to remove the device the force applied seemed to be a reasonable clinical response to the difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.(b)(4).

Event Description

It was reported the procedure was to treat the right superficial femoral artery (sfa) via left groin access with calcification and tortuosity noted in the vessel.The vessel was 6 mm, atherectomy was not used and the vessel was prepared with a 6x200 mm armada 18 percutaneous transluminal angioplasty (pta) catheter to 14 atmospheres at 3 minutes.The 6x100 mm supera self expanding stent (ses) was thought to have been successfully deployed; however, it partially deployed in the 6fr 45 cm sheath and upon removal the tip of the delivery system caught on the sheath.The physician pulled hard when some resistance was noted during removal and the tip separated.Two snares were attempted and other balloon techniques but the tip could not be removed.The tip was able to be dragged to the left common femoral via the left groin access and the tip was embedded to the vessel with an additional stent.There was a 2+ hour delay in the procedure as a result of the additional intervention.No additional information was provided.

• 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: 15633843
• MDR Text Key: 302023032
• Report Number: 2024168-2022-10822
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211829
• UDI-Public: 08717648211829
• 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
• Report Date: 10/19/2022

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 Model Number: S-60-100-120-P6
• Device Catalogue Number: S-60-100-120-P6
• Device Lot Number: 2081761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2022
• Initial Date FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• 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: 6FR 45 CM DESTINATION SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 93 KG