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

Model Number	HX2035
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Transient Ischemic Attack (2109)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gore® helex septal occluder instructions for use state that removal of an occluder should be considered if the selected occluder is too small and allows excessive shunting.The reported information suggests the physician implanted the device despite a "voluminous shunt".
Event or Problem Description
It was reported the physician implanted a 35mm gore® helex septal occluder to close an atrial septal defect on (b)(6) 2014.During the initial procedure, a 30mm gore® helex septal occluder was initially selected and deployed but was too small for the defect and was removed.The physician then selected the 35mm gore® helex septal occluder which was implanted despite a "voluminous shunt".The defect was not balloon sized.In (b)(6) 2019, the patient presented with a transient ischemic attack.On (b)(6) 2020, the patient had a positive bubble study, indicating a shunt and was referred for surgery.The physician later opted to close the shunt with a 35mm cribriform, which was implanted over the helex device on (b)(6) 2020.The patient was doing well following the procedure.
Event or Problem Description
It was reported the physician implanted a 35mm gore® helex septal occluder to close an atrial septal defect on (b)(6) 2014.During the initial procedure, a 30mm gore® helex septal occluder was initially selected and deployed but was too small for the defect and was removed.The physician then selected the 35mm gore® helex septal occluder which was implanted despite a "voluminous shunt".The defect was not balloon sized.In (b)(6) 2019, the patient presented with a transient ischemic attack.On (b)(6) 2020, the patient had a positive bubble study, indicating a shunt and was referred for surgery.The physician later opted to close the shunt with a 35mm cribriform, which was implanted over the helex device on (b)(6) 2020.The patient underwent transthoracic echocardiography (b)(6) 2020 that showed no residual shunt by color flow doppler.The patient is doing well.
Additional Manufacturer Narrative
Corrected information: the patient underwent closure of the residual defect on (b)(6) 2020.The initial report noted that this procedure took place on (b)(6) 2020.

• Brand Name: GORE HELEX SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9734869
• Report Number: 2017233-2020-00106
• Device Sequence Number: 16225661
• Product Code: MLV
• UDI-Device Identifier: 00733132607013
• UDI-Public: 00733132607013
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: HX2035
• Device Catalogue Number: HX2035
• Device Lot Number: 10963852
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 102