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

Catalog Number SE-05-040-120-6F

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

Patient Problem Thrombosis (2100)

Event Date 10/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).At this point it was decided to take the patient to the operating theatre later that evening to surgically remove the stent delivery system tip and do an elective embolectomy which was performed successfully.No additional information was provided.Medical devices: dil cath: 5.5x40mm armada 18, guide wire: command 18 st 300cm , sheath: 6f 45cm, stent: absolute pro.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 to treat a de novo lesion located in the moderately calcified, mildly tortuous, proximal superficial femoral artery (sfa).Pre-dilatation was performed with a 6.0 x 40 mm armada 18 balloon prior to deployment of the stent.The 5 x 40 mm supera stent was deployed proximal and overlapping an existing absolute pro stent that had been deployed 5 years previously.Deployment was successful and the supera stent was released from the delivery system.Attempts were made to capture the tip into the delivery system; however, the tip and the catheter were 'sandwiching' in the proximal end of the deployed supera stent and were caught on the stent edge threatening to elongate the stent implant.An attempt was made to advance the delivery catheter through both stents to help capture the tip outside the stents; however, this was unsuccessful.It was observed that the problem could be that the guide wire was tracked on the medial side of the vessel causing the tip of the catheter to catch on the stent edge.The sfa was then punctured on the ipsilateral side and an armada 18 balloon was used to post-dilate the proximal lumen of the stent to allow for removal of the tip; however, after jiggling and tugging on the catheter sharply this proved unsuccessful.A 6 x 40 mm armada 35 balloon was crossed to the overlapping area of the stents to secure both stents in place and the catheter was pulled releasing the tip of the catheter leaving the tip in the patient.After catheter removal angiography revealed a small thrombosis noted in the tibioperoneal trunk.

Manufacturer Narrative

(b)(4).Visual inspection was performed on the returned device.The tip detachment was confirmed.Based on the reported information, it appears that the distal end of the delivery system was bent or smashed such that during retraction of the thumbslide/tip, the tip caught on the stent and ultimately detached.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 reported patient effect of thrombosis is listed in the supera instructions for use as known patient effect associated with the use of the device.The investigation determined that the reported difficulty removing, tip detachment, additional patient effects and treatment were due 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.

• 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: 7007788
• MDR Text Key: 91289467
• Report Number: 2024168-2017-08757
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: SE-05-040-120-6F
• Device Lot Number: 7080361
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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