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

Catalog Number S-60-150-120-P6

Device Problems Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Difficult or Delayed Activation (2577); Difficult to Advance (2920)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 11/01/2018

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.The investigation determined that the reported difficulties were likely due to case circumstances.It is likely that the heavily calcified lesion caused the stent to elongate during deployment which resulted in the stent to partially deploy within the introducer sheath.As a result, withdrawing the delivery system into the introducer sheath with the stent partially deployed likely caused the tip to detach when the withdrawal forces of pulling the partially expanded stent through the reduced clearance of the introducer sheath exceeding the tensile strength of the tip lumen.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 heavily calcified lesion in the right superficial femoral artery with a vessel diameter of 6 mm.A 6x65 sheath was placed and pre-dilatation was performed with a 6.0mm balloon dilatation catheter.A 6.0x150 mm supera self-expanding stent system (sess) was advanced with resistance noted in the popliteal artery and the stent was deployed.No difficulty was noted with the sess during deployment; however, the stent was difficult to deploy due to the patient anatomy.The end of the stent caught at the end of the sheath; when the physician attempted to remove the sess, the tip separated.An attempt was made to remove the tip with a snare, but the tip could not be removed successfully.The tip was crushed to the vessel wall and an additional stent was implanted to cover the tip.The supera stent was elongated more than 10% but remains in the target lesion.There was no adverse patient effect.There was a delay in the procedure but not clinically significant as there was no impact to the patient.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: 8092151
• MDR Text Key: 128012633
• Report Number: 2024168-2018-08982
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211843
• UDI-Public: 08717648211843
• 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
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 6121561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• 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