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

Model Number	S-60-120-120-P6
Medical Device Problem Codes	Material Separation (1562); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported the procedure was to treat the right superficial femoral artery (sfa) with short chronic total occlusion.A 6f sheath was used.The vessel was 6 mm and laser atherectomy was performed.A 6.0x120 mm supera self-expanding stent (ses) was advanced to the lesion without resistance and deployed.Fluoroscopy was used to confirm the stent had fully emerged/deployed when removing the delivery system.However, when a balloon was being advanced for post dilatation, the stent seemed blocked and it was observed that the supera tip had separated and was stuck at the proximal entry of the supera stent.The sheath that was already in the anatomy was advanced to capture the tip but also removed the implanted stent.No additional stent was implanted.Manual pressure was used to complete the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.Return device analysis noted that the 6f sheath was returned with a 3.0 armada 14 balloon catheter inserted inside.It appears that the balloon had been inflated and was likely used to help remove the separated tip and subsequently the implanted stent.It was confirmed that there was no device issue with the armada balloon.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The tip separation was confirmed.The difficult to remove could not be confirmed due to the condition of the device.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.The investigation was unable to determine the cause of the tip stretch and separation.It may be possible it may be possible that the thumbslide was not retracted and the system lock was not locked prior to removal resulting in the tip catching in the stent; however, this could not be confirmed.The additional therapy was due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The armada device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
Subsequent to the initially filed report the following information was received: the superficial femoral artery (sfa) was pre-dilated with a 6.0 balloon prior to deployment of the supera self-expanding stent (ses).There was no reported resistance removing the supera stent system.Angiography showed good wall apposition and no post-dilatation was needed.The 3.0 armada balloon was advanced to possibly treat the tibial artery, but could not cross and it was observed via additional imaging that the tip of the supera ses had detached and was blocking the proximal end of the supera stent.The 3.0 armada balloon was then used to retrieve the tip of the supera and inadvertently removed the implanted stent.No additional treatment was performed and no additional stent was implanted.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: 10631779
• Report Number: 2024168-2020-08277
• Device Sequence Number: 11564401
• Product Code: NIP
• UDI-Device Identifier: 08717648211836
• UDI-Public: 08717648211836
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020

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: 12/31/2021
• Device Model Number: S-60-120-120-P6
• Device Catalogue Number: S-60-120-120-P6
• Device Lot Number: 0011361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 11/03/2020
• 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: 3.0 ARMADA14 BALLOON CATHETER; 6FR TERUMO SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR