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

Model Number	S-45-040-120-P6
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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, the supera self-expanding stent system and stent were removed without fluoroscopy.It should be noted that the supera peripheral stent system instructions for use (ifu) states: under fluoroscopy, remove the device from the guide wire and evaluate the improved luminal quality of the treated area.Precaution: should unusual resistance be felt at any time during stent deployment the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.The deviation of the ifu does not appear to have caused/contributed to the reported difficulties.As there was no reported damage noted to the device during the inspection prior to use, it is possible that interaction with the heavily tortuous and heavily calcified anatomy resulted in the ratchet being unable to properly engage and release the stent from the delivery system thus resulting in reported activation failure/ deployment failure and the reported mechanical jam; however, this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily tortuous and heavily calcified lesion in the distal superficial femoral artery.The 4.5x40mm supera self-expanding stent system (sess) was prepared per the instructions for use (ifu).Following pre-dilatation with an unspecified 5mm balloon at nominal pressure, the sess was advanced.The sess was being deployed per the ifu; however, it only deployed about 10mm and then the thumbslide stopped working and it could not be further deployed.The sess was locked and the sess and stent were removed together without resistance.The sess and stent were removed without fluoroscopy.The procedure was successfully completed with a 4.5x16mm supera stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Common Device Name: 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: 15176167
• Report Number: 2024168-2022-08585
• Device Sequence Number: 5034516
• Product Code: NIP
• UDI-Device Identifier: 08717648225925
• UDI-Public: 08717648225925
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: S-45-040-120-P6
• Device Catalogue Number: S-45-040-120-P6
• Device Lot Number: 2011161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: .014 BOSTON; SHEATH: TERUMO 6X45CM
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 62 KG