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 Codes	Material Separation (1562); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2021
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 incidents and/or complaints reported from this lot.Based on the information provided, the reported difficulties appear to be related to circumstances of the procedure.It is likely that the proximal end of the stent partially deployed within the introducer sheath causing the stent to be narrowed and when the tip was retracted to the sheath and locked into place, the tip caught on the narrowed portion of stent causing resistance with the thumbslide and separation of the tip.The stent likely released from the introducer sheath when devices were removed as a single unit.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 performed to treat a heavily calcified, non-tortuous left superficial femoral artery.Pre-dilatation was done with a 5.0 balloon.Atherectomy was not used.During deployment of the 4.5x100mm supera stent, the stent was deployed too close to the 6f sheath (55cm) and the tip separated.The tip remained on the wire and was removed with the wire and sheath as a single unit.Outside of the patient, the 6f sheath was cut to confirm the tip was removed.The stent remains implanted in the target lesion.Per the physician, there may have been a little resistance when the system lock was rotated and the deployment lock was locked in position (in line with the thumb slide).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: 11308147
• Report Number: 2024168-2021-01064
• Device Sequence Number: 4117809
• Product Code: NIP
• UDI-Device Identifier: 08717648225987
• UDI-Public: 08717648225987
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/10/2021

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: 03/31/2022
• Device Model Number: S-45-100-120-P6
• Device Catalogue Number: S-45-100-120-P6
• Device Lot Number: 0041461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1