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

Catalog Number SE-05-200-120-6F

Device Problems Detachment Of Device Component (1104); Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.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 is likely that the narrowed portion of the stent was due to the lesion site which was described as a heavily calcified, 100% stenosed total occlusion, and when the thumb slide was retracted during deployment, the tip was unable to pass through the narrowed stent causing it to detach.The investigation determined that the reported difficulties were due to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

It was reported that the procedure was to treat a de novo, mildly tortuous, heavy calcified, 100% stenosed total occlusion in the mid superficial femoral artery (sfa) through a 6f sheath via an ipsilateral antegrade approach.The vessel diameter was 5.5 mm.Pre-dilatation was performed with a 5x200 mm non-abbott balloon dilatation catheter at 16 atmosphere prior to advancing a 5 x 200 mm supera self-expanding stent system (sess) into the patient anatomy.During deployment of the supera stent it was noted that the catheter tip of the sess got stuck in the stent struts and broke off.After deployment, it was noted that there was a narrowed segment of the stent, which was thought to be from the detached tip.Post-dilatation was performed and the stent was confirmed to be well apposed to the vessel wall.The separated tip was retrieved using a snare device.There was no reported adverse patient sequela or a clinically significantly delay in the procedure.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: 7492530
• MDR Text Key: 107559769
• Report Number: 2024168-2018-03362
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: SE-05-200-120-6F
• Device Lot Number: 8011862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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