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

Model Number	S-45-120-120-P6
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot history record (lhr) could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported.Based on the information provided, a conclusive cause for the reported difficulty could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right popliteal artery.A 4.5x120mm supera self expanding stent system (sess) was advanced to the lesion.After deploying the stent, the physician pulled back the delivery system and the stent pulled back into the 6 french sheath.Both were removed from the anatomy and another supera was successfully implanted to complete the procedure.There was no adverse patient effect or clinically significant delay in procedure.No additional information was provided.

• Brand Name: SUPERA PERIPHERAL 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: 9842803
• Report Number: 2024168-2020-02537
• Device Sequence Number: 2886229
• Product Code: NIP
• UDI-Device Identifier: 08717648226007
• UDI-Public: 08717648226007
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2020

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 Model Number: S-45-120-120-P6
• Device Catalogue Number: S-45-120-120-P6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/17/2020
• 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: 6FR SHEATH