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

Model Number	S-45-100-120-P6
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
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 other complaints.Based on the information provided, a definitive cause for the tip detachment could not be determined.It may be possible that the tip was not retracted and locked in place prior to removal causing interaction with the stent or anatomy resulting in separation; however, this could not be confirmed.The additional treatment to snare the detached 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 this was a percutaneous interventional procedure to treat the distal superficial femoral artery (sfa).The 4.5x100 mm supera stent was implanted and the delivery system was removed from the patient without incident.When a post-dilatation balloon was unable to advance down a guide wire, a fluoroscopy image showed that the tip of the supera delivery system had detached and was in the distal sfa.The separated tip was removed with a snare.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information 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: 10960640
• Report Number: 2024168-2020-10219
• Device Sequence Number: 10908488
• Product Code: NIP
• UDI-Device Identifier: 08717648225987
• UDI-Public: 08717648225987
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2020

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: 03/31/2021
• Device Model Number: S-45-100-120-P6
• Device Catalogue Number: S-45-100-120-P6
• Device Lot Number: 9040461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 12/07/2020
• 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