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 Detachment Of Device Component (1104)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.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 heavily calcified superficial femoral artery.Reportedly, the lesion was prepared with correct dilatation.The 5.0 x 150 mm supera self-expanding stent system (sess) advanced to the target lesion, but resistance was felt during deployment.When the sess was removed from the anatomy, it was noticed that the distal tip was missing.The tip remains embedded in the vessel, proximal to the stent.There was no clinically significant delay in procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspection was performed on the returned device.The deployment issue was unable to be confirmed due to the condition of the returned device; however, the tip detachment 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 revealed no other incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Cine image was returned and reviewed by an abbott clinical specialist.The results of the review indicate that the reported tip detachment was possibly due to deployment of the stent against resistance.Although deployment stent against resistance may have contributed to the tip detachment, a cause for the resistance encountered could not be determined.A letter will not be requested.A review of the x-rays was received from james stokes today via e-mail and resides in documentum.The following conclusion statement was provided:, it was reported that a heavily calcified superficial femoral artery (sfa) lesion was properly prepared prior to stent deployment.The heavy calcium burden is evident on the images provided although further preparation might have been necessary to provide an optimal vessel diameter prior to stent deployment.During deployment, the operator reported that resistance was felt.Deployment continued and upon removal of the delivery system the catheter tip was missing, eventually being located within the sfa.Per the instructions for use (ifu) - section 9.5, stent deployment, #1 the following precaution is listed: precaution: should unusual resistance be felt at any time during stent system advancement or stent deployment the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.Based upon the report this precaution may not have been followed and may have lead to the tip detachment.

• 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: 7079827
• MDR Text Key: 93624193
• Report Number: 2024168-2017-09363
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• 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-05-150-080-6F
• Device Lot Number: 7080161
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2018
• 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): Other