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

Catalog Number S-50-120-120-P6

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2018

Event Type  malfunction  

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 additional relevant information.The ht command guide wire referenced in describe event or problem and concomitant medical products is being filed under a separate manufacturer report number.

Event Description

It was reported that the procedure was to treat a chronic total occlusion in the non-tortuous, heavily calcified, 100% stenosed, distal superficial femoral artery (sfa).A 018 hi-torque (ht) command guide wire was advanced to the lesion and crossed.A 5.0 x 120 mm supera stent delivery system (sds) was advanced, but met resistance with the guide wire and became stuck.The sds was unable to be pulled back over the guide wire; therefore, the sds and guide wire were removed from the anatomy as a unit.A new non-abbott 018 guide wire and a new 5.0 x 120 mm supera sds were used to successfully complete the procedure.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.No additional information provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual and functional inspections were performed on the returned devices.The reported difficulties were confirmed.It is likely that during advancement of the supera, the clearance between the guide wire lumen and the guide wire outer surface became reduced causing resistance.Further attempts to move the self expanding stent system (sess) over the guide wire likely caused the devices to become frozen together.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 determined the difficulties were likely due to case circumstances.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: 7236177
• MDR Text Key: 99006150
• Report Number: 2024168-2018-00769
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: S-50-120-120-P6
• Device Lot Number: 7032061
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2018
• 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 Age: 70 YR
• Patient Weight: 80