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

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2015

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in the superficial femoral artery (sfa).An unknown supera self-expanding stent system (sess) was advanced toward the target lesion and the stent was deployed.The system locks were not re-locked prior to withdrawing the system and the tip separated; however, the tip stayed on the guide wire.As the guide wire/tip was being withdrawn the stent moved and did not remain within the intended site.The stent was in the mid to proximal sfa, the system was pulled back and the stent migrated to the iliac.The exact distance is unknown.The tip was retrieved by withdrawing the guide wire without intervention.No resistance was felt during withdrawal.There was no adverse patient effect.There was no clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the previously filed medwatch, additional reported information indicates that the stent migrated to the iliac artery and no additional treatment was performed.

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed.Reviews of the lot history record and complaint history could not be conducted because the lot number was not provided.Additionally, it should be noted that the supera instructions for use states: following confirmed implantation of the supera stent, retract the thumb slide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into the locked position, in line with the thumb slide.Based on the information reviewed, there is no evidence to indicate the presence of a potential issue/observation caused by, or related to the design, manufacture, or labeling of the device.

Manufacturer Narrative

(b)(4).

• 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: 4795136
• MDR Text Key: 5831700
• Report Number: 2024168-2015-02956
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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