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

Model Number	S-60-100-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Activation Failure (3270); Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device.The reported deployment difficulty, popping sound and difficulty removing was unable to be confirmed as the was returned 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 complaints reported from this lot.The investigation was unable to determine a cause for the reported difficulties.Based on the reported information, it appears that the stent was not fully released prior to removal.It may be possible that the distal sheath of the supera delivery system was entrapped or kinked within in the anatomy such that the ratchet was unable to engage the stent properly preventing full deployment; however, this could not be confirmed.The tip separation likely occurred as the partially deployed stent was being withdrawn into the introducer sheath causing the reported resistance during removal and causing the tip to separate due to the reduced clearance which was likely the reported ¿popping¿ sound that was heard.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 lesion in the heavily calcified superficial femoral artery (sfa).The supera stent delivery system was advanced into the patient anatomy and the stent was deployed.The stent seemed to deploy without issue and was thought to be fully deployed.The delivery system was removed; however, resistance was noted when the delivery system caught.The device stopped moving, and a popping noise was heard.On angiography, it was noted that the nose cone had detached.The nose cone caught on the stent.The physician continued with removal of the stent delivery system, and it was noted that the stent was being removed with the sheath.The nose cone remained in the sheath and was removed with the sheath and stent.There was no adverse patient effect and no clinically significant delay.A third supera was implanted to complete 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: 10698099
• Report Number: 2024168-2020-08695
• Device Sequence Number: 19807994
• Product Code: NIP
• UDI-Device Identifier: 08717648211829
• UDI-Public: 08717648211829
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 10/19/2020

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: 12/31/2021
• Device Model Number: S-60-100-120-P6
• Device Catalogue Number: S-60-100-120-P6
• Device Lot Number: 0012761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/19/2020
• 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: TERUMO DESTINATION SHEATH, 6.0 X 45
• Patient Age: 53 YR
• Patient Weight: 97