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

Model Number	S-45-120-120-P6
Medical Device Problem Codes	Material Separation (1562); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.It may be possible that the distal shaft was bent or entrapped within the anatomy such that the ratchet efficiency was compromised and was unable to fully release the stent.Once the stent delivery system was pulled back slightly nose cone detached; however, this cannot be confirmed.The tip detachment likely occurred due to the stent not being fully released and when withdrawing the system back.If the delivery system is withdrawn proximally with a portion of the stent not fully released or partially deployed in the introducer sheath, the tip assembly over-mold will not be able to pass the area of reduced diameter and with resistive forces due to lack of sheath diameter clearance for the tip, the tip will detach.The additional attempt to retrieve the nose cone was due to case circumstances.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 target lesion in the heavily calcified superficial femoral artery (sfa).The supera stent delivery system was advanced to the target lesion and stent deployment was initiated.When about half of the stent was deployed, resistance was noted, due to the patient anatomy.The stent delivery system was pulled back slightly and it was noted that the delivery system catheter nose cone detached.Stent deployment continued; however, due to the issues, the stent did not fully cover the target lesion.After the stent was deployed and the stent delivery system was removed, an attempt was made to retrieve the separated nose cone; however, the nose cone was unable to be retrieved.The nose cone embolized to the sfa and remains in the patient anatomy.A second supera stent delivery system was implanted to treat the remaining lesion.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: 11554976
• Report Number: 2024168-2021-02282
• Device Sequence Number: 17155584
• Product Code: NIP
• UDI-Device Identifier: 08717648226007
• UDI-Public: 08717648226007
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 03/23/2021

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: 08/31/2021
• Device Model Number: S-45-120-120-P6
• Device Catalogue Number: S-45-120-120-P6
• Device Lot Number: 9092461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/23/2021
• 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