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

Model Number	S-55-100-120-P6
Medical Device Problem Codes	Material Separation (1562); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.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 lesion located in the common femoral artery that was non tortuous, non-calcified and 70% stenosed.The supera stent was deployed without issue; however, during removal of the stent delivery system, it was noted that the tip detached and remained in the introducer and the proximal stent was attached to the delivery system.The stent was removed with the delivery system.There was no adverse patient effect or a clinically significant delay in procedure.There was no additional treatment provided.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported activation failure could not be confirmed as the delivery system was not returned.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.The investigation was unable to determine a cause for the reported difficulties.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 and pulling the stent out with the delivery system; however, without having the delivery system to examine the position of the system lock, 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.

• 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: 9702870
• Report Number: 2024168-2020-01445
• Device Sequence Number: 19285138
• Product Code: NIP
• UDI-Device Identifier: 08717648226120
• UDI-Public: 08717648226120
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020

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: 05/31/2021
• Device Model Number: S-55-100-120-P6
• Device Catalogue Number: S-55-100-120-P6
• Device Lot Number: 9060461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 80