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

Catalog Number SE-06-030-120-6F

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Thrombosis (2100)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Implant date - estimated.The reported patient effects of thrombosis is listed in the supera instructions for use as a known patient effects associated with the use of the device.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the lot numbers were not provided.Based on the information reviewed, there is no indication of a product quality issue.The investigation was unable to determine a conclusive cause for the reported stent migration and patient effects; however the treatment appears to be related to the circumstances of the procedure.The 6 x 60 mm supera referenced is being filed under separate medwatch report.

Event Description

It was reported the procedure was to treat a long thrombotic occlusion of a vein graft in the mid popliteal artery with a 6 x 30 mm and 6 x 60 mm supera stents this year in february.The patient suffered from popliteal artery entrapment syndrome (paes) which was treated from the vascular surgeons in 2015.A vein graft was implanted besides the native popliteal artery from p1 to p3 to disable the paes.The patient returned with the vein graft and supera stents occluded with thrombosis.Additionally, under fluoroscopy, the 6 x 60 mm supera stent was noted to be fractured and the 6 x 30 mm supera stent was dislocated proximally.A guide wire was not able to cross; therefore, the patient was sent to surgery.It seems that the paes still exists, and they now will try to disable it with a new vein graft landing near the trifurcation below the knee.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: 6111734
• MDR Text Key: 60285897
• Report Number: 2024168-2016-08068
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08975370022650
• UDI-Public: (01)08975370022650
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SE-06-030-120-6F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2016
• 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
• Treatment: STENT: 6 X 60 MM SUPERA
• Patient Outcome(s): Hospitalization; Required Intervention