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

Model Number	S-60-120-120-P6
Medical Device Problem Codes	Material Separation (1562); Stretched (1601); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other supera stent referenced is filed under a separate medwatch report.Na.
Event or Problem Description
It was reported that on (b)(6) 2021 a supera stent was implanted in the superficial femoral artery (sfa).On (b)(6) 2021, the procedure was performed to treat a heavily calcified lesion in the left popliteal artery.The vessel diameter was 6mm.A 6mm angioplasty balloon was used to prep the vessel.The 6.0x120mmx120cm supera self-expanding stent system (sess) (lot# 9061961) was advanced to the target lesion and deployed.Resistance was noted during removal of the sess.Troubleshooting was performed; the introducer sheath had to be pulled back and the stent deployed but was elongated and stretched to the previously implanted supera stent, which was difficult to visualize.The tip of the supera detached in the sfa but remained on the guide wire.A balloon was used to aid in removal of the tip from the anatomy.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 not returned for evaluation.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 indication of a lot specific product quality issue.Based on the information provided, a definitive cause for the reported difficulties could not be determined.It may be possible that the proximal end of the super a stent was partially deployed within the introducer sheath resulting in resistance during removal and elongation of the stent.Additionally, it may be possible that during the attempts to release the stent from the introducer sheath and/or delivery system, the tip separation occurred; however, this could not be confirmed.The unexpected medical intervention to retrieve the separated tip was related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 11387956
• Report Number: 2024168-2021-01518
• Device Sequence Number: 13757959
• Product Code: NIP
• UDI-Device Identifier: 08717648211836
• UDI-Public: 08717648211836
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 03/21/2021

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: 05/31/2021
• Device Model Number: S-60-120-120-P6
• Device Catalogue Number: S-60-120-120-P6
• Device Lot Number: 9061961
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 014" X 315CM BAREWIRE; DESTINATION SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR