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

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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis (2100); Numbness (2415)

Event Date 08/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.In the absence of a reported part number, the udi cannot be calculated.There was no reported device malfunction and the product was not returned as the stent remains in the patient.A review of the lot history record and complaint history of the reported device could not be conducted because the part and lot numbers were not provided.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of thrombosis, as listed in the supera instructions for use, is a known patient effect.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

It was reported that approximately one year ago, the patient with a history of acute non-st-elevation myocardial infarction (nstemi) had a supera stent implanted in their right femoral artery.The patient was compliant with dual antiplatelet drug therapy (dapt) consisting of clopidogrel and aspirin without interruption.The patient was recently re-hospitalized with the symptoms of a sensation of numbness and coldness.The patient was diagnosed with intra stent thrombosis which was confirmed by angiography.The patient was treated with anticoagulant medication and continuing medical management.No additional stents were implanted to treat the thrombosis.No additional information was provided.

Manufacturer Narrative

(b)(4).Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

Subsequent to the previously filed medwatch report, additional information received states that the initial procedure was performed on 10/05/2016 and approximately 10 months later, on (b)(6) /2017 due to tiredness after a walk of 50 meters.Doppler ultrasound was performed in the popliteal segment and arteriography was requested, which was performed on (b)(6) 2017, finding thrombosis of the sfa, stent with hyperplasia and occlusion of the tibial artery.Balloon angioplasty and medication management was performed.

• 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: 6852570
• MDR Text Key: 85436931
• Report Number: 2024168-2017-07363
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SE-06-120-120-6F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2017
• 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: 83 YR
• Patient Weight: 72