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

Catalog Number SE-05-180-120-6F

Device Problem Detachment Of Device Component (1104)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 01/24/2018

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 is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during preparation of a 5x180mm supera self-expanding stent system (sess) the tip broke off the device during the flush step.The sess was not used in the patient.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual inspection was performed on the returned device.The tip detachment was confirmed.Additionally, the stent was partially deployed.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 determined that the reported difficulties were likely due to case circumstances.Based on the analysis of the returned device, there was blood throughout the entire delivery system consistent with the device being advanced into the anatomy or at minimum, into the introducer sheath.Although it was reported that the tip separation was noted after the device was unpacked, the partial deployment of the stent suggests that the thumbslide may have been slightly advanced during or after advancement into the anatomy.Additionally, with the stent partially deployed from the distal sheath, the tip separation likely occurred when the delivery system was retracted into the reduced clearance of the introducer sheath with the partially deployed stent.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

The returned device analysis identified that the supera self-expanding stent system (sess) was returned with blood in and on the sheath indicating that the device had been advanced into the anatomy or at minimum, into the introducer sheath.Additionally, the distal end of the stent was partially deployed.Follow-up with the account stated that the device was not used in the patient and the tip separation occurred outside the patient anatomy.No additional information was provided.

• 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: 7393351
• MDR Text Key: 104420575
• Report Number: 2024168-2018-02443
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: SE-05-180-120-6F
• Device Lot Number: 7011661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• 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