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

Model Number	S-65-080-120-P6
Medical Device Problem Codes	Material Separation (1562); Activation Failure (3270); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion in the left external iliac vein (eiv).Pre-dilatation was performed with an unspecified device and a 6.5x80mm supera stent was advanced and deployed.However, the stent had difficulty detaching from the stent delivery system as it was only partially deployed.The edge of the stent didn't deploy.Even though the thumb slide was advanced/pulled back, the stent didn't release from the delivery shaft.At some point during attempted removal the stent detached from the shaft and migrated from the left eiv to the left common vein.The stent was noted to be deployed in healthy tissue.The tip of the delivery catheter separated and treatment if any is unknown.There was no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported activation failure and migration could not be confirmed as the stent was already fully deployed.The tip detachment was confirmed.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 revealed no other similar complaints reported from this lot.The investigation was unable to determine a cause for the reported deployment difficulties and tip detachment resulting in foreign body in patient.It may be possible that the distal sheath of the delivery system was entrapped or bent in the anatomy preventing the ratchet ears from engaging the stent properly to allow full release of the stent; however, this could not be confirmed.The tip detachment may be the result of retracting the delivery system with the stent partially deployed.Additionally, the stent migration was likely the result of the stent releasing once the delivery system was retracted.The tip detachment may be the result of retracting the delivery system with the stent partially deployed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9: device available for evaluation was updated from "asku" to "yes".

• 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: 12131380
• Report Number: 2024168-2021-05793
• Device Sequence Number: 4700451
• Product Code: NIP
• UDI-Device Identifier: 08717648226267
• UDI-Public: 08717648226267
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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: 09/30/2022
• Device Model Number: S-65-080-120-P6
• Device Catalogue Number: S-65-080-120-P6
• Device Lot Number: 0100861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/27/2021
• 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: Other