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); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2018

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: a visual and dimensional inspection was performed on the returned device.The reported deployment issue and difficulty removing was unable to be confirmed as the stent had already been fully deployed.The tip separation was 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 likely related to circumstances of the procedure.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 moderately calcified superficial femoral artery.A 5.5 x 150 mm supera peripheral stent system was used and the stent was deployed after retracting the thumbslide and unlocking the deployment lock.The device did not meet any resistance during advancement; however, the device met resistance during removal; therefore, the physician stopped retracting the device.It was then noted under fluoroscopy that the catheter tip separated inside an unspecified introducer sheath.Therefore, the introducer sheath and the device were removed as a single unit, and it was noted that the stent, which was partially deployed, had dislodged inside the introducer sheath.The stent was then manually removed via laser arteriotomy at the access site.Then, a different unspecified introducer sheath and another unspecified supera device were used to successfully complete the procedure.There was a clinically significant delay in the procedure.No additional information was provided at this time.

• 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: 7496434
• MDR Text Key: 107661102
• Report Number: 2024168-2018-03392
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226168
• UDI-Public: 08717648226168
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/08/2018

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: S-55-150-120-P6
• Device Lot Number: 7112861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 36 YR
• Patient Weight: 59