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

Catalog Number S-60-150-120-P6

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant product(s): sheath: 6 fr pinnacle.Evaluation summary: visual 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.The investigation determined the reported difficulties were likely related to circumstances of the procedure.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 moderately tortuous and moderately calcified bifurcation of the superficial femoral artery.Pre-dilatation was performed with a 6.0 x 150 mm non-abbott balloon catheter at nominal pressure.There was resistance with the anatomy when advancing an 8.0 x 150 mm supera self-expanding stent system to the lesion.After deploying 30-40 mm of the stent, the thumbwheel ratchet would not engage and it could not be moved forward or backwards.While removing the delivery system, including the stent, when the tip was pulled into the 6f sheath, the tip stuck and the shaft and tip separated so the entire system was removed from the anatomy.After attempting to use two non-abbott devices, an absolute pro self-expanding stent was successfully deployed to complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.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: 6344000
• MDR Text Key: 68115310
• Report Number: 2024168-2017-01359
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211843
• UDI-Public: (01)08717648211843(17)171031(10)5111962
• 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: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 5111962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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 Age: 80 YR
• Patient Weight: 91