MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number S-45-060-120-P6

Device Problems Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a moderately calcified popliteal artery.An unspecified supera peripheral stent system was used and met resistance with the anatomy during advancement.The tip of the device then separated during deployment.Reportedly, the system lock and the deployment lock had not been rotated into the locked position (in line with the thumb slide) during use.Therefore, the patient was sent to surgery to remove the tip and the deployed stent.There was a clinically significant delay in the procedure.No additional information was provided.

Event Description

Updated case details: it was reported that the procedure was to treat a moderately calcified popliteal artery.A 4.5x60mm supera peripheral stent system was advanced and met resistance with the anatomy.Predilatation was performed and the supera stent was deployed in the p1/p2 popliteal segment; however, when trying to re-sheath the delivery catheter, the delivery component became entrapped in the p2 segment of the stent and fractured.A 5.0mm coronary balloon was attempted to advance over the 0.014 miracle bros guide wire to expand the stent around the retained fragment but this was unsuccessful.Next a 0.014 fielder xt guide wire was attempted to advance around the retained fragment to get a balloon next to the delivery component, which was unsuccessful.Finally, a 9.0 gooseneck snare was advanced and attempted to entrap the device which was unsuccessful.At this point, the decision was made to abort the procedure and call vascular surgery for consultation regarding fragment removal.The guide wires were removed.The sheath was exchanged for a standard 6f x 12cm sheath which was sutured into place.The deployed stent and tip were removed two days later.There was a clinically significant delay in the procedure.Reportedly, the system lock and the deployment lock had not been rotated into the locked position (in line with the thumb slide) during use.No additional information was provided.

Manufacturer Narrative

Device codes: 1212 labeled.Internal file number - (b)(4).Correction - device codes 2017 and 1528 removed.Evaluation summary: visual inspection was performed on the returned device.The reported difficulty removing, and entrapment was not confirmed as it was based on case circumstances.The tip detachment was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation determined that the reported difficulties were related to case circumstances.Based on the reported information, it appears that the tip became caught on the stent and separated during the attempt to re-sheath the tip and lock the system lock.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
• Type of Device: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8156043
• MDR Text Key: 130161728
• Report Number: 2024168-2018-09590
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: S-45-060-120-P6
• Device Lot Number: 6110461
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/03/2018
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 45