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

Lot Number 13506371

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Headache (1880); Loss of Vision (2139); Numbness (2415)

Event Date 04/21/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to gore a 25mm gore® helex® septal occluder was successfully implanted on (b)(6) 2015 to close an atrial septal defect (asd) balloon stretched to 10mm prior to placement.The patient was referred for asd closure following positive bubble study upon an interesting presentation.It was reported that on (b)(6) 2015 the patient reported an itchy rash and generalized joint pain.The patient was advised at that time to stop the plavix and continue asa alone.On (b)(6) 2015 the patient reported the itchy rash went away after cessation of plavix.The patient also reported experiencing visual aura after strenuous physical activity (climbing) and was advised to cease this activity and general straining until a negative bubble study was performed.Echocardiogram with bubble study at rest and valsalva on (b)(6) 2015 were negative, indicating compete closure of the asd.The patient reported experiencing occasional aura at this time without accompanying migraine.Brilinta was started and aspirin (asa) was reduced from 325mg to 81mg daily.On (b)(6) 2015 it was reported the patient was not approved for brilinta, stopped asa at two months and has been on no anti-platelet medication for the past month.Migraine frequency and intensity improving significantly.On (b)(6) 2016 it was reported the patient continues to experience occasional visual auras (once every 2 months).The patient has resumed diving activities.The patient was referred to dr.Alex feldman for tcd to further explain ocular migraines.On (b)(6) 2017 the patient continues to experience visual auras and related symptoms attributed to ocular of complex migraines.The patient has returned to technical scuba diving and following a technical dive experienced skin bends and was evaluated by brain mri at (b)(6) hospital with normal results.The device was seen at this time in good position within the interatrial septum with no residual shunting detected.The patient was seen on (b)(6) 2019 for an unscheduled visit at boulder community emergency department following loss of vision in the right eye and right cheek numbness.Mri and hypercoagulable evaluation believed normal.Not evaluated for afib at that time.No evidence of thrombus on device noted.Further echo imaging recommended to evaluate for small thrombus.Further evaluation for any thromboembolic condition recommended.Echocardiogram performed.The patient did go on coumadin and had a tee echocardiogram the week of (b)(6) 2019.There was no thrombus on the device at that time.The physician was unsure if the patient had stopped coumadin.Echocardiogram performed on (b)(6) 2019.Device found to be perfectly clean with no thrombus noted.Patient no longer on coumadin.

Manufacturer Narrative

H6: updated results/conclusions code 2 for imaging evaluation.An image was received for review and it showed the gore helex septal occluder was stable with no residual shunting around it.There is not enough evidence on the images to confirm that there are any echogenic mass formed on the occluder.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Updated device code.Updated conclusion code.Based on the information provided that no thrombus was confirmed, medwatch report #2017233-2020-00011 is being retracted.Mri performed (b)(6) 2019 indicated no evidence of thrombus on device.Transesophageal echocardiogram the week of (b)(6) 2019: there was no thrombus on the device at that time.Echocardiogram performed on (b)(6) 202019.Device found to be perfectly clean with no thrombus noted.An image was received for review and it showed the gore helex septal occluder was stable with no residual shunting around it.There is not enough evidence on the images to confirm that there are any echogenic mass formed on the occluder.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: GORE HELEX SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9557271
• MDR Text Key: 185670557
• Report Number: 2017233-2020-00011
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 13506371
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR