MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE CARDIOFORM SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

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

Patient Problem Arrhythmia (1721)

Event Date 02/15/2020

Event Type  Injury  

Manufacturer Narrative

The patient information used is from the patient demographics provided in the literature article.The gore® cardioform® septal occluder instructions for use list arrhythmia as a potential device or procedure-related adverse event.Gevorgyan fleming r, kumar p, west b, et al.Comparison of residual shunt rate and complications across 6 different closure devices for patent foramen ovale.Catheter cardiovasc interv.2019;1¿8.Https://doi.Org/10.1002/ccd.28527.

Event Description

This information was received through literature article "comparison of residual shunt rate and complications across 6 different closure devices for patent foramen ovale" published in catheterization & cardiovascular interventions, 15 february 2020.In this retrospective study, the efficacy of six different patent foramen ovale (pfo) closure devices used in the united states over an 18-year period, was assessed by measuring the degree of residual shunt after implantation.In addition, the safety of pfo closure was assessed for serious procedure- and device-related adverse events.Indications for pfo closure included cerebral vascular accident, migraine headaches, tia versus complex migraine, myocardial infarction, orthodeoxia, and =1 diagnosis.The article reports 320 patients received quantitative assessment of right-to-left shunting both before and after percutaneous closure from february 2001 to july 2019.The article further reports that 104 patients received a gore® cardioform septal occluder.The remaining patients received gore® helex® septal occluder, amplatzer cribriform, amplatzer aso, cardioseal, and amplatzer pfo devices.The gore® cardioform septal occluder had a 100% effective closure rate.Adverse events listed for the gore® cardioform® septal occluder include, nine cases of atrial fibrillation and one case of supraventricular tachycardia.

• Brand Name: GORE CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10971501
• MDR Text Key: 220690112
• Report Number: 2017233-2020-01511
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2020
• 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): Required Intervention
• Patient Age: 55 YR