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

Catalog Number SE-04-100-120-6F

Device Problems Detachment Of Device Component (1104); Difficult or Delayed Positioning (1157); Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).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 lesion in the heavily calcified, narrow popliteal artery.A 4 x 100 mm supera veritas stent delivery system (sds) was selected for the procedure.The sds was advance to the lesion and significant resistance was felt during the first 2 to 3 advancements and retractions of the thumb slide and the stent implant elongated.The physician then continued deployment of the stent implant with no further resistance.The sds was removed from the anatomy and during the final angiography it was observed that the tip of the sds was in the stent implant.Several unsuccessful attempts were made to retrieve the sds tip which took 90 minutes.As there was flow in the peroneal artery, the decision was made to leave the sds tip in the anatomy.No other information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the reported deployment issue was unable to be confirmed as the stent had already been fully deployed.The tip separation was confirmed.In this case, it is likely that the distal sheath was bent or entrapped within the vessel causing the noted resistance during deployment.Additionally, withdrawing the delivery system with a partially deployed stent may cause the tip to detach when the withdrawal forces of pulling the partially deployed stent through the restricted area of the introducer sheath exceeds the tensile strength of the tip lumen.It should be noted that the supera instruction for use states: following confirmed implantation of the supera stent, retract the thumb slide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into the locked position, in line with the thumb slide.Additionally, the ifu states: precaution: should unusual resistance be felt at any time during 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 of the reported lot revealed no other incidents.The investigation determined that the reported difficulties was due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Additional information: it was further reported that when the abbott vascular sales rep looked at the device it appeared that the stent delivery system was removed without retracting the thumbwheel and with the locking mechanism unlocked.No other 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: 6560106
• MDR Text Key: 74933988
• Report Number: 2024168-2017-04060
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• 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-04-100-120-6F
• Device Lot Number: 6071861
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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