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

Catalog Number SE-05-060-120-6F

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2017

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

Event Description

It was reported the procedure was performed to re-treat a tortuous and occluded fistula.The 5 x 60 mm supera veritas stent delivery system (sds) was advanced to the fistula, and the stent was deployed.After deployment, the sds was pulled back with force due to resistance with the deployed stent, and the tip of the sds separated.The tip was succcessfully snared from the anatomy.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and the reported deployment issue was unable to be confirmed as the stent had already been fully deployed.The tip separation was confirmed.It may be possible that the distal sheath was bent or entrapped within the vessel causing the noted resistance during deployment.Additionally, it may be possible that the thumb slide was not retracted and the system lock was not locked prior to withdrawal causing the tip to catch on the stent and separate; 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.The investigation was unable to determine a conclusive cause for the reported difficulties.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: 6378728
• MDR Text Key: 69099844
• Report Number: 2024168-2017-01810
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: SE-05-060-120-6F
• Device Lot Number: 6090261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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