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

Catalog Number SE-06-100-080-6F

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that an interventional procedure was performed using an unknown supera self-expanding stent (ses).The ses was successfully deployed, however when the ses was removed, the tip was missing.The tip was retrieved from the patient, ending the procedure.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: initial reporter updated.Evaluation summary: visual inspections were performed on the returned device.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 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

Subsequent to the initially filed report, the following information was received: it was reported that the procedure was to treat a lesion in the superficial femoral artery with heavy calcification.The vessel was prepared with a 7.0 x 100 mm armada 35 balloon catheter and a 6.0 x 100 mm supera veritas self-expanding stent (ses) was successfully deployed.During removal of the ses under fluoroscopy, there was slight resistance with anatomy and when the ses was removed, the tip was missing.The tip was retrieved from the patient using a snare, ending the procedure.

• 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: 7622400
• MDR Text Key: 111828501
• Report Number: 2024168-2018-04719
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: SE-06-100-080-6F
• Device Lot Number: 7032061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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