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	Material Separation (1562); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion in the popliteal artery with moderate calcification, mild tortuosity and 60% stenosis.The vessel diameter was 4 mm, atherectomy was not performed and pre-dilatation was performed with a non-abbott 5x100 mm balloon at 8 atmospheres for 2 minutes.The 4.5x40 mm supera self expanding stent system (sess) failed to deploy the stent and the shaft tip of the device detached but remained with the delivery system.The delivery system and separated portion were removed from the patient without any complications and there were no adverse patient effects.A 4.5x80 mm supera stent was used to complete the procedure.There was no reported clinically significant delay in the procedure.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation was able to be confirmed.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device.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, it is possible that interaction with the moderately calcified, mildly tortuous and 60% stenosed anatomy and/or inadvertent mishandling resulted in the noted device damages (multiple sheath/shaft bends) thus during deployment resulted in the ratchet being unable to properly engage and release the stent from the delivery system; resulting in the reported activation failure.Further interaction with the anatomy/other devices and/or inadvertent mishandling resulted in the reported tip separation/noted tip jacket/inner member separations; however this cannot be confirmed.The investigation determined a conclusive cause for the reported/noted difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 17309490
• Report Number: 2024168-2023-07426
• Device Sequence Number: 12577974
• Product Code: NIP
• UDI-Device Identifier: 08717648225925
• UDI-Public: 08717648225925
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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: 05/31/2024
• Device Model Number: S-45-040-120-P6
• Device Catalogue Number: S-45-040-120-P6
• Device Lot Number: 2062761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2022
• 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: COMMAND 18 ST GUIDE WIRE; CORDIS INTRODUCER 6FX11CM
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 72 KG