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

Catalog Number UNK SUPERA

Device Problem Break (1069)

Patient Problems Ischemia (1942); Stenosis (2263)

Event Date 02/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number -(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event: estimate.In the absence of a reported part number, the udi cannot be calculated.Implant date: estimate.Product performance engineering reviewed the incident information.A review of the lot history record and complaint history of the reported device could not be conducted since the part and lot numbers were not provided.The reported patient effect of ischemia and stenosis are listed in the supera peripheral stent system instructions for use (ifu) as known patient effects of the procedure.The investigation determined the reported stent fracture and subsequent patient effects appear to be related to circumstances of the procedure.The stenosis and ischemia were likely results of the stent fracture, thus requiring hospitalization and subsequent treatment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Attachment: article titled, bend but dont break? a case of supera stent fracture in the popliteal artery.

Event Description

Information received via article titled: bend but don't break? a case of supera stent fracture in the popliteal artery.It was reported the patient presented with lifestyle limiting right calf claudication, ischemic rest pain (rutherford category 3-4), and a right popliteal occlusion.The patient underwent a complex intervention attempt at recanalization; however were unsuccessful.Following 3 months of ongoing medical optimization and a walking program, the patient returned for a peripheral angiography and a repeat attempt at recanalization of the popliteal occlusion.Orbital atherectomy was performed followed by pre-dilatation with a 4.0x100mm angioplasty balloon at high pressure.A 4.0x100mm supera self expanding stent was then deployed across the popliteal lesion.Final angio demonstrated a patent, well expanded stent in the right popliteal artery and intact tibioperoneal vessels distally, without any evidence of dissection, distal embolization, or perforation.Three months later, the patient returned with recurrence of ischemic symptoms involving his right calf and foot.Ultrasonography demonstrated significant velocity increases across the distal superficial femoral artery and proximal popliteal artery, suggestive of high grade stenosis within the proximal stent.The patient underwent a repeat diagnostic angiography which noted a fracture of the supera stent, with complete non-union of stent struts in the mid stent and a long segment of severe (80%) in-stent restenosis proximal and distal to the fracture.Subsequent angioplasty was performed across the stent fracture with a scoring balloon.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: 7325731
• MDR Text Key: 101956854
• Report Number: 2024168-2018-01679
• 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: literature
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/08/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 59 YR