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

Model Number	S-55-100-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Material Twisted/Bent (2981); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, the patient presented for a right superficial femoral artery (sfa) with moderate tortuosity and calcification.For vessel preparation, atherectomy was performed using a phoenix catheter, and two balloon dilatation catheters were successfully utilized.The supera stent deliver system advanced to the lesion site without issues reported.Stent deployment was performed with successful wall apposition.During delivery system removal, the supera tip (nose cone) caught the deployed stents edge.The nose cone site had bent and had grabbed the stents proximal edge.During device retraction, the stent elongated with the entangled nose cone, and was explanted.The nose cone had not separated from the device and all was removed from the anatomy.There was no adverse patient effect and there was no clinically significant delay reported.Another device (non-abbott) was used in replacement without further issues reported.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
The device was received.The investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure and difficult to remove were unable to be replicated in a testing environment due to the condition of the returned device.The reported stretched stent was unable to be confirmed.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.The investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that during removal interaction with the deployed stent resulted in the tip getting caught; resulting in the reported activation failure and difficult to remove.Manipulation of the device resulted in the reported bent nose cone/noted device damages (kinked, stretched, collapsed inner member).The reported stretched stent was not confirmed.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: 13712489
• Report Number: 2024168-2022-02387
• Device Sequence Number: 6268216
• Product Code: NIP
• UDI-Device Identifier: 08717648226120
• UDI-Public: 08717648226120
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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: 07/31/2023
• Device Model Number: S-55-100-120-P6
• Device Catalogue Number: S-55-100-120-P6
• Device Lot Number: 1081061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• 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: 10 CM STANDARD SHEATH
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 96 KG