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

Catalog Number 42065020-120

Device Problems Unintended System Motion (1430); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 performed to treat a non-tortuous and moderately calcified de novo lesion in the common femoral artery.A 6f introducer was advanced and the lesion was prepared with a 7mm unspecified balloon catheter.A 6.5x20mm supera peripheral stent system was advanced and deployed; however, at the end of deployment there was difficulty detaching the stent from the delivery system.After several attempts the stent finally released from the delivery system, but due to handling, the stent was slightly pulled back from its initial position.A 6x30mm supera stent was deployed to successfully treat the uncovered lesion distal to the first deployed stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual inspection was performed on the returned device.The deployment difficulties were not able to be confirmed as the stent had already been deployed.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 was unable to determine a cause for the reported deployment difficulties.It may be possible that the distal sheath was bent or entrapped in the anatomy such that the ratchet was unable to engage proximal end of the stent properly to fully release it from the delivery system; however, this could not be confirmed.Additionally, based on the reported information, the stent movement was due to handling during the deployment difficulty, the stent was slightly pulled back from its initial position.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: 8028365
• MDR Text Key: 125788203
• Report Number: 2024168-2018-08341
• 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: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 42065020-120
• Device Lot Number: 8050761
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/31/2018
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: 6F BIOTRONIK; GUIDE CATHETER: 6F BIOTRONIK