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

Model Number	S-55-100-120-P6
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Exemption number e2019001.
Event or Problem Description
It was reported that this was a percutaneous treatment of a right superficial femoral artery (sfa), heavily calcified lesion.Vessel preparation was performed per instructions for use.Pre-dilatation was performed with a 5.5x100 balloon.The supera stent delivery system (sds) advanced to the lesion and the stent deployment started without issue.Once at the end of the deployment, the 2nd lock was attempted to be unlocked for a full push through and stent release, however the lock would not unlock.As troubleshooting, the delivery system was angulated to the right and left at 45 degrees, the thumbslide was advanced and retracted several times, however, the second lock would not unlock.The sheath was slowly retracted and the stent finally released.The stent remained implanted at the intended area.There was no stent stretching observed.There was no adverse patient effect.A 30-minute delay occurred for troubleshooting, however, there were no clinical symptoms associated.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
Visual and functional inspection was performed on the returned device.The reported failure of the deployment lock was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.The investigation determined that the difficulty with the deployment lock appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: SUPERA PERIPHERAL 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: 9221883
• Report Number: 2024168-2019-12839
• Device Sequence Number: 14009139
• Product Code: NIP
• UDI-Device Identifier: 08717648226120
• UDI-Public: 08717648226120
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

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: 03/31/2021
• Device Model Number: S-55-100-120-P6
• Device Catalogue Number: S-55-100-120-P6
• Device Lot Number: 9040461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 01/30/2020
• 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: 6FRENCH DESTINATION SHEATH.
• Patient Age: 65 YR
• Patient Weight: 90