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

Catalog Number S-55-060-120-P6

Device Problems Positioning Failure (1158); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the vessel.The stent delivery system was reported to be discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during a procedure of the non-tortuous, non-calcified popliteal artery, the supera stent was partially deployed in the vessel, but became caught in an unspecified way and was stretched to the common femoral artery where it became fully deployed but not in the target lesion.The stent remains in a fixed position and is fully apposed to the vessel wall.A second 5.5 x 40 mm supera stent was used to treat the lesion without reported adverse patient effect.Although the procedure was delayed about 15 minutes it was not clinically significant.No additional information was provided.

Manufacturer Narrative

(b)(4).The device is not returning for evaluation as it remains in the patient; therefore, a failure analysis of the complaint device could not be completed.Based on the reported information, there is no indication of a product quality issue with respect to manufacture, design or labeling.A definitive cause for the reported difficulties could not be determined.The foreign body in patient is due to operational context.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 4628
• Manufacturer (Section G): WEBSTER, TX USA REG#3005325609; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5286646
• MDR Text Key: 33232912
• Report Number: 2024168-2015-07436
• 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: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: S-55-060-120-P6
• Device Lot Number: 02407058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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
• Patient Outcome(s): Other