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

Catalog Number 42055200-120

Device Problems Difficult to Advance (2920); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2018

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 is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a mildly tortuous, heavily calcified and totally occluded mid superficial femoral artery.An unspecified supera stent was implanted in the p2 segment and an attempt was made to implant a 5.5 x 200 mm supera stent; overlapping the previous supera stent.However, the stent failed to completely deploy after multiple attempts; therefore, the device was removed through the introducer sheath and an unspecified stent was implanted to successfully complete the procedure.There was a delay in the procedure; however, it was not clinically significant.There were no adverse patient effects.No additional information was provided.

Event Description

Subsequent to the initial report, a correction was made.The 5.5 x 22 mm supera stent met initial resistance with the anatomy during advancement.No additional information was provided.

Manufacturer Narrative

Device codes: 2920 labeled.(b)(4).Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The resistance during advancement and deployment difficulty was not confirmed.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 related to case circumstances.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: 8119889
• MDR Text Key: 128904436
• Report Number: 2024168-2018-09165
• 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: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 42055200-120
• Device Lot Number: 8090461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1