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

Catalog Number SE-04-060-080-6F

Device Problems Detachment Of Device Component (1104); Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Physical Resistance (2578); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2015

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion located in the heavily tortuous, 85% stenosed av fistula.Predilatation of the lesion was performed with a 3 mm, 4 mm and then 5 mm balloon catheters.While the stent delivery system was being tracked on the non-abbott guide wire to reach the treatment location, a lot of resistance was felt passing a very tight bend/angle in the vessel to enter the fistula.After having deployed partially within the stenotic lesion, strong resistance was felt during pull back of the thumb advancer due to the very tight bend/angle in the vessel.Suddenly the resistance was gone and it was observed that the tip of the delivery catheter was lost.The stent implant was then successfully deployed in the arterial side; however was becoming elongated as the ratchet did not grab correctly.After stent deployment, the deployment locks were closed.A snare was used to retrieve the tip.The final outcome for the patient was considered successful and the patient is doing well.The patient returned 4 days later for an unrelated venous problem.Angiography confirmed the stenoses was fully opened by the supera.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.

Manufacturer Narrative

(b)(4).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.

Manufacturer Narrative

(b)(4).Correction: it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed.Cine image review concluded that the likely cause for the detachment of the tip is the interaction between the tip of the device upon removal and the area of high resistance that was noted upon delivery of the device.A review of job traveler revealed no non-conformances that would have contributed to the reported event.The results of the historical data review and query of the electronic complaint handling database revealed no other incidents reported from this lot.Based on the information reviewed, there is no indication the issue was caused by, or related 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 462
• Manufacturer (Section G): WEBSTER, TX USA REG#3005325609; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4782034
• MDR Text Key: 5798180
• Report Number: 2024168-2015-02834
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: SE-04-060-080-6F
• Device Lot Number: 02360002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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
• Treatment: GUIDE WIRE: V18 BOSTON SCIENTIFIC
• Patient Outcome(s): Required Intervention