MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA 6F; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number	S-55-040-120-P6
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2020
Type of Reportable Event	Malfunction
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 similar incidents and/or complaints from this lot.Based on the information provided, a definitive cause for the migration could not be determined.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 performed to treat a de novo lesion in the mildly tortuous, heavily calcified right superficial femoral artery.A non-abbott sheath was advanced along with a 5.5x40mm supera self-expanding stent system (sess).After the physician took their hand off the device, the sess moved 2-3cm by itself.The sess was advanced to the target lesion when the sess moved in the same way again.The sess was advanced, and the stent was implanted successfully.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: SUPERA 6F
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9957204
• Report Number: 2024168-2020-03630
• Device Sequence Number: 11412082
• Product Code: NIP
• UDI-Device Identifier: 08717648226069
• UDI-Public: 08717648226069
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2020

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: 08/31/2020
• Device Model Number: S-55-040-120-P6
• Device Catalogue Number: S-55-040-120-P6
• Device Lot Number: 8091761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1