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

Catalog Number SE-06-080-120-6F

Device Problems Difficult or Delayed Positioning (1157); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion in the mid, common femoral artery with a 6 x 80 mm supera self-expanding stent system (sess).The sess was advanced to the lesion and crossed.During deployment of the stent implant, the final 1 cm of the stent would not deploy even though the thumb slide was advanced to the distal most position on the handle.The sess was pulled back and the stent implant completely deployed, but was elongated.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual inspections were performed on the returned device.The deployment issue and stent elongation was not confirmed as the stent was not returned.Cine images were returned and reviewed by an abbott vascular clinical specialist.The reviewer concluded the following: the media provided for review does appear to confirm the reported deployment failure in that the stent appears to have been stretched to release the stent and complete the deployment.It is unknown what the root cause for this failure is.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 was unable to determine a cause for the reported difficulties.It may be possible that the distal sheath of the delivery system was entrapped or bent in the anatomy such that the ratchet was unable to engage the stent properly resulting in the reported resistance with the thumbslide and preventing full deployment; however, this could not be confirmed.The elongation was likely the result of retracting the delivery system with the stent partially deployed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the previously filed medwatch report, additional information received states that there was resistance felt while pushing the thumbslide and the last move was not possible.The procedure took approximately an additional 30 minutes to perform as the physician disassembled the device handle to deploy the stent.No additional information was provided.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7637846
• MDR Text Key: 112456747
• Report Number: 2024168-2018-05025
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2018

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: 03/31/2020
• Device Catalogue Number: SE-06-080-120-6F
• Device Lot Number: 8041761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 07/12/2018
• Supplement Dates FDA Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention