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

Catalog Number 42065100-080

Device Problems Failure to Advance (2524); Contamination /Decontamination Problem (2895); Difficult to Advance (2920)

Patient Problem No Patient Involvement (2645)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual, dimensional, functional and scanning electron microscopy (sem) inspection was performed on the returned device.The reported blockage was confirmed.The investigation was unable to determine a definitive cause for the blockage.The potential improper loading of the proximal end of the guide wire may have caused the noted damage to the interior of the supera guide wire lumen and the material formed the noted blockage that prevented further advancement of the guide wire; however, this could not 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.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that during preparation of the devices for the procedure, the guide wire would not advance through the supera lumen.The guide wire was exchanged to a new guide wire, but it wouldn't go through the supera lumen as well.Although, the supera guide wire port had been flushed prior to use.The supera was not used.A non-abbott device was used to complete the procedure.There was no patient involvement.There was no clinically significant delay in the procedure.No additional information was provided.Return device analysis revealed that there was a clear substance visible in the guide wire lumen, at the distal end of the ratchet stem.

• 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: 7785712
• MDR Text Key: 117284688
• Report Number: 2024168-2018-06273
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 42065100-080
• Device Lot Number: 8022161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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