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

Catalog Number S-50-120-120-P6

Device Problems Entrapment of Device (1212); Material Separation (1562); Activation Failure (3270)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/18/2018

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 additional relevant information.

Event Description

It was reported that the supera stent delivery system was advanced to the superficial femoral artery, heavily calcified lesion without issue.During deployment, the stent partially deployed, however, further stent deployment was not possible.The thumbslide was advanced but no further stent deployment was noted.As troubleshooting, the system was locked and unlocked but nothing would allow for further deployment.As treatment, a contralateral access site was gained and a snare was advanced to the partially deployed stent.While all was removed as a single unit, difficulty was encountered and a shaft separation was observed.All was removed from the patient's anatomy and a non-abbott device was used in replacement.There was a clinically significant delay as bleeding from both access sites was now noted and pressure had to be held to obtain hemostasis.The event resolved and the patient is in stable condition.No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspections were performed on the returned device.The deployment difficulty was unable to be confirmed as the stent had already been deployed.The entrapment in the vessel was unable to be confirmed as it was based on case circumstances.The shaft 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.It should be noted that hematoma or hemorrhagic event, with or without surgical repair is listed in the supera instruction for use (ifu) as a potential adverse event associated with the use of the device.The investigation was unable to determine a conclusive cause for the reported deployment issue.The tip separation, shaft separation and subsequent patient effects were likely due to case circumstances.It may be possible that the distal shaft was entrapped or restricted within the anatomy such that the ratchet efficiency was compromised and was unable to fully release the stent.However, this could not be confirmed.Additionally, withdrawing the delivery system into the introducer sheath with a partially deployed stent likely caused the tip and proximal shaft to detach when the withdrawal forces of pulling the partially deployed stent through the reduced clearance of the introducer sheath exceeded the tensile strength of the tip lumen and causing the shaft to pull out from the coupler to distal end cap (dec).Based on the information reviewed, 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
• 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: 8053258
• MDR Text Key: 126628659
• Report Number: 2024168-2018-08621
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: S-50-120-120-P6
• Device Lot Number: 7120761
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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
• Patient Age: 91 YR
• Patient Weight: 80