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

Catalog Number S-55-150-120-P6

Device Problems Detachment Of Device Component (1104); Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual inspections were performed on the returned device.The deployment difficulty was unable to be confirmed as the stent had already been deployed.The tip detachment was confirmed.The tip detachment likely occurred due to pulling the partially deployed stent through the restricted area of the introducer sheath exceeds the tensile strength of the tip lumen.The investigation was unable to determine a conclusive cause for the reported deployment issue.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.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 chronic totally occluded, moderately tortuous, and mildly calcified lesion in the proximal femoral artery.Following pre-dilatation with an armada 35 balloon catheter at 20 atmospheres, a 5.5x150mm supera self-expanding stent system (sess) was advanced; however, could not fully deploy even though the deployment lock was unlocked and the thumb slide was advanced to the most distal position on the handle.A larger sheath was advanced to successfully retrieve the stent from the patient anatomy.The delivery system was removed under fluoroscopy.The procedure was successfully completed with a new 5.5x150mm supera sess.There were no adverse patient effects and no clinically significant delay in the procedure.Additional information was received: the return device analysis found that the tip jacket and inner member were separated at the distal end of the ratchet stem.Follow-up with the account indicated that this occurred when an attempt to release the delivery system was made.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: 7571758
• MDR Text Key: 110166336
• Report Number: 2024168-2018-04173
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226168
• UDI-Public: 08717648226168
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 6081561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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