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

Catalog Number	S-55-120-120-P6
Medical Device Problem Codes	Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the superficial femoral artery (sfa) with mild calcification, mild tortuosity and 95% stenosis.The 5.5x120mm supera self expanding stent system (sess) was advanced to the lesion on a 0.018 abbott guide wire.The system lock was opened and the thumb slide was advanced to the most distal position on the handle with no resistance noted; however, the stent was only partially deployed with repeated pushing of the thumb slide.The sess was retracted back to the sheath under fluoroscopy to the introducer to confirm the stent did not fully deploy.Another same size supera sess completed the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure and mechanical jam were 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, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the distal sheath of the delivery system was entrapped or bent in the mildly calcified, mildly tortuous and 95% stenosed anatomy such that the ratchet was unable to properly/fully engage the stent resulting in difficulty advancing the thumbslide/ mechanical jam and the reported deployment difficulty/activation failure.Manipulation of the device and/or inadvertent mishandling resulted in the noted sheath kink; likely contributing to the reported difficulties.Likely after removal from the anatomy and/or during shipment back for analysis manipulation of the device resulted in the stent to become fully deployed.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: 18841415
• Report Number: 2024168-2024-02764
• Device Sequence Number: 15317829
• Product Code: NIP
• UDI-Device Identifier: 08717648226144
• UDI-Public: 08717648226144
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 03/05/2024

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: 07/31/2024
• Device Catalogue Number: S-55-120-120-P6
• Device Lot Number: 2081761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• 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: 0.18 ABBOTT GUIDE WIRE
• Patient Sex: Unknown