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 Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Embolism/Embolus (4438)
Date of Event	05/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported 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 incidents and/or complaints reported from this lot.The reported patient effect of embolism is listed in the supera instruction for use (ifu) as a known potential patient effect associated with the use of the device.The investigation was unable to determine a cause for the tip detachment resulting in embolism and unexpected medical intervention.It may be possible that the tip detachment occurred due to not retracting the thumbslide to sheath the tip and locking the system lock prior to removal causing the tip to catch on the stent and/or anatomy resulting in separation during removal; 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 target lesion in the left proximal superficial femoral artery (sfa) to external iliac artery, via the right common femoral artery.A 6.0 x 45 non-abbott sheath was advanced up and over to the target lesion.Pre-dilatation was performed using a 5.0 x 80 mm dilatation catheter over a 0.018 guide wire.Additional dilatation was performed using a drug coated balloon.The 6.5 x 80 mm supera stent delivery system was advanced without issue to the target lesion and deployed without issue.After stent deployment, it was noted that the nose cone had detached.A 6.0 x 20 mm non-abbott dilatation catheter was advanced, in an attempt to embed the nose cone into the vessel wall; however, the nose cone embolized to a small branch of the profunda artery.The separated nose cone remains in the patient anatomy and there are no plans to remove it.The procedure ended with the patient in stable condition.There was no clinically significant delay.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: 11924871
• Report Number: 2024168-2021-04609
• Device Sequence Number: 3362485
• Product Code: NIP
• UDI-Device Identifier: 08717648226267
• UDI-Public: 08717648226267
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/02/2021

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: 10/31/2021
• Device Model Number: S-65-080-120-P6
• Device Catalogue Number: S-65-080-120-P6
• Device Lot Number: 9111961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/02/2021
• 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: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 62