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

Catalog Number S-55-060-120-P6

Device Problem Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/03/2018

Event Type  Injury  

Manufacturer Narrative

(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 performed to treat a 90% stenosed, heavily calcified lesion in the left popliteal artery.Intravascular ultrasound (ivus) was used to verify vessel diameter prior to stenting.The vessel measured 4.7-4.8mm.Pre-dilatation was performed with a 6.0mm balloon.The 5.5x60mm 6f supera self-expanding stent system was advanced without resistance and the stent was deployed in the target lesion without issue.An unspecified device was then advanced to perform post-dilatation of the deployed stent; however, fluoroscopy revealed that the stent had migrated into the superficial femoral artery (sfa) where supera stents had been implanted in a previous procedure.The physician then post-dilated the migrated supera stent in the sfa and the procedure concluded without any additional treatment.There was no adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspections were performed on the returned device.The reported migration was unable to 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 conclusive cause for the reported stent migration.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: 8182123
• MDR Text Key: 131040462
• Report Number: 2024168-2018-09903
• Device Sequence Number: 1
• Product Code: NIP
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: S-55-060-120-P6
• Device Lot Number: 7121261
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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: 80 YR