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

Catalog Number SE-05-150-080-6F

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.It may be possible that the distal shaft was entrapped in the anatomy such that the ratchet was unable to engage the stent properly; however, this could not be 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 was unable to determine a cause for the reported deployment difficulty.The surgical procedure to remove a portion of the stent 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

It was reported that the procedure was performed to treat a lesion in the superficial femoral artery (sfa).Following pre-dilatation, a 5x150mm supera peripheral stent system was advanced and the markers were lined up exactly where the lesion site was located.The distal marker was at the mid sfa and the proximal marker at bifurcation of the sfa and deep femoral.The stent was deployed all the way to the sfa bifurcation without any problems; however, the stent deployment did not finish at the bifurcation as planned.Part of the stent was left in the sheath so deployment was continued and finished outside the vessel.The patient was transferred to the theatre for a cut down at the groin area.The vascular surgeon cut the stent that was out of the vessel and left the rest inside the vessel.The patient is currently fine.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: 7520813
• MDR Text Key: 108482630
• Report Number: 2024168-2018-03668
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: SE-05-150-080-6F
• Device Lot Number: 7110961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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
• Patient Age: 61 YR
• Patient Weight: 71