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

Model Number	S-60-030-120-P6
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/22/2021
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 similar incidents reported from this lot.Based on the information provided, a definitive cause for the tip detachment could not be determined.It may be possible that during pre-dilation the vessel may have caused a misalignment triggering the slight tip detachment during deployment however, this could not be confirmed.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 non-calcified, mildly tortuous right superficial femoral artery.Pre-dilatation was done with a 6.0x40mm armada 18 balloon inflated to nominal at 8atm for 2 minutes.The 6.0x30mm supera self-expanding stent system (sess) was advanced using a 6f sheath (55cm), up and over the iliac, with no resistance.Then upon deployment, it was observed under fluoroscopy that the nose cone was starting to become detached.Therefore, the physician quickly finished deploying the stent and a decision was made to retract the thumb slide back to remove the system with the guidewire as a single unit.After the devices were successfully removed from the patient, the physician pulled on the nose cone and it became easily fully detached.The target lesion was treated.The patient is stable.No other issues noted.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: 11280237
• Report Number: 2024168-2021-00878
• Device Sequence Number: 16349607
• Product Code: NIP
• UDI-Device Identifier: 08717648211881
• UDI-Public: 08717648211881
• 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
• 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): 02/04/2021

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: 06/30/2021
• Device Model Number: S-60-030-120-P6
• Device Catalogue Number: S-60-030-120-P6
• Device Lot Number: 9071161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1