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

Catalog Number SE-06-200-080-6F

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: guide wire: boston scientific v-18 300 cm; sheath: cook medical 6f 55 cm; stent: cook medical 6 x 80 mm zilver ptx.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 long de novo lesion in a moderately calcified superficial femoral artery (sfa).A 6 x 80 mm non-abbott stent implant was successfully deployed in the distal end of the lesion near the first popliteal-hunter artery.A 6 x 200 mm supera stent delivery system (sds) was advanced to treat the proximal area and to completely cover the sfa.After deployment of the stent, it was noticed that the last 1 to 2 cm of the proximal end of the stent had not deployed.The deployment lock was unlocked and the remaining part of the stent implant was deployed.During removal of the sds from the anatomy, the tip of the sds separated and remained on the non-abbott guide wire.An unspecified balloon catheter was advanced into the anatomy and inflated to trap the separated tip on the guide wire and they were removed from the anatomy as a unit.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: visual and functional inspection was performed on the returned device.The reported deployment issue was unable to be confirmed; however, the tip detachment was confirmed.Based on the reported information and analysis of the returned device, it appears that the last 1 to 2 cm of stent did not released because the deployment lock was not unlocked as instructed in the instruction for use (ifu).Additionally, the tip detachment appears to be due to the user not retracting the thumbslide to the starting position on the handle and locking the system lock prior to removal.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 likely related to user technique.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: 7363379
• MDR Text Key: 103266793
• Report Number: 2024168-2018-02082
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: SE-06-200-080-6F
• Device Lot Number: 6072061
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/22/2018
• Date Manufacturer Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention