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

Model Number	S-65-080-120-P6
Medical Device Problem Codes	Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported stent elongation could not be determined as the stent was already fully deployed and not returned.The tip separation was 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 complaints reported from this lot.The investigation was unable to determine a cause for the reported stent elongation and tip separation.In this case, as it was reported that the stent elongated even though it showed as released from the delivery system on fluoroscopy, it may be possible that the tip detachment was due to not retracting the thumbslide to sheath the tip and locking the system lock prior to removal resulting in the tip catching in the stent causing elongation during withdrawal and resulting in tip separation; however, this could not be confirmed.The additional treatment to remove the tip was related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a greater than 60% stenosed, mildly calcified lesion in the superficial femoral artery (sfa).A 6.5x80mm supera peripheral self-expanding stent system (sess) was advanced to the lesion and the stent deployed.Upon withdraw of the delivery system, the stent elongated even though it showed as released from the delivery system on fluoroscopy.They continued to remove the delivery system and the nose cone completely separated and remained in the anatomy.A balloon and wire were used to trap the nose cone and pull it into the sheath, to completely remove it from the anatomy.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
• MDR Report Key: 12011313
• Report Number: 2024168-2021-05050
• Device Sequence Number: 3197638
• Product Code: NIP
• UDI-Device Identifier: 08717648226267
• UDI-Public: 08717648226267
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: S-65-080-120-P6
• Device Catalogue Number: S-65-080-120-P6
• Device Lot Number: 0031161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 136