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

Catalog Number S-55-080-120-P6

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The additional supera device is being filed under separate a medwatch report.

Event Description

It was reported that the procedure was performed to treat a lesion in the distal superficial femoral artery to the proximal popliteal artery with mild calcification and no tortuosity.The lesion was dilated with an unspecified 5.0 mm balloon dilatation catheter and a dissection occurred.A 5.5 x 80 mm supera self expanding stent system was advanced to treat the dissection.On deployment with the proximal end of the stent 20cm away from the 7f introducer sheath, it was noted that the stent was being pulled backwards with every partial throw of the thumb slide.The stent was therefore removed partially deployed with slight resistance from the anatomy and introducer sheath.An additional 5.5 x 100 mm supera stent was advanced; however, the same deployment problem occurred and the stent was again removed partially deployed from the anatomy with resistance.A third supera stent was successfully deployed at the target lesion to treat the dissection.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual inspections were performed on the returned device.The deployment issue and difficulty removing was not confirmed.It should be noted that the supera instructions for use, states: should unusual resistance be felt at any time during stent system advancement or stent deployment the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.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 revealed no other similar incidents.The investigation determined the reported difficulties were due to case circumstances as it is likely that the stent diameter for both supera stents was too large for the vessel diameter causing the stents to elongate and pull backwards during deployment.The resistance during removal was the result of pulling the partially deployed stent back through the vessel and introducer sheath.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: 8103056
• MDR Text Key: 128399609
• Report Number: 2024168-2018-09039
• 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: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: S-55-080-120-P6
• Device Lot Number: 8022261
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/19/2018
• Initial Date Manufacturer Received: 11/02/2018
• Initial Date FDA Received: 11/26/2018
• Supplement Dates Manufacturer Received: 11/30/2018
• Supplement Dates FDA Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 7F, 65CM INTRODUCER SHEATH
• Patient Age: 69 YR
• Patient Weight: 86