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

Model Number GSX0025A

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

Patient Problems Stroke/CVA (1770); Endocarditis (1834); Thrombus (2101)

Event Date 05/07/2020

Event Type  Injury  

Manufacturer Narrative

The gore® cardioform septal occluder instructions for use states: adverse events associated with the use of the occluder may include, but are not limited to: endocarditis, tia or stroke, thrombosis or thromboembolic event resulting in clinical sequelae.

Event Description

It was reported to gore a 25mm gore® cardioform septal occluder was implanted in (b)(6) 2018 to close a patent foramen ovale.The patient was seen in follow-up at the cardiology clinic in (b)(6) 2020 and was reported to be doing well with no concerns noted on the transthoracic echocardiogram (tte).On (b)(6) 2020 the patient presented to the emergency room with expressive aphasia and weakness on the right side.Upon arrival to the emergency room the patient was treated with tissue plasminogen activator (tpa) and taken to the angiography suite where reperfusion injury was already noted.A tte performed on (b)(6) 2020 did not show thrombus on the device.A ct scan on (b)(6) 2020 noted reperfusion injury with hemorrhagic conversion of the stroke.A transesophageal echocardiogram performed on (b)(6) 2020 noted large thrombi on the device in the left atrium.Repeat blood cultures x3 were positive for staph infection and the patient was started on antibiotics.It has been reported that the patient was discharged to a rehabilitation center and is making a good recovery and that antibiotic treatment continues.At this time surgery for device removal is being postponed due to the risk associated with the recent head bleed.There have been no further clinical events following the initial event on (b)(6) 2020.

Manufacturer Narrative

H6: updated conclusion code 3 for sterilization evaluation.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

D7: added explant date.H6: added method, results, conclusions code 3 for sterilization evaluation.The gore® cardioform septal occluder instructions for use states: adverse events associated with the use of the occluder may include, but are not limited to: endocarditis, tia or stroke, thrombosis or thromboembolic event resulting in clinical sequelae.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 CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10123799
• MDR Text Key: 195586936
• Report Number: 2017233-2020-00404
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631025
• UDI-Public: 00733132631025
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2019
• Device Model Number: GSX0025A
• Device Catalogue Number: GSX0025A
• Device Lot Number: 17400383
• 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): Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 74