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

Catalog Number GSX0030A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Embolism (1829)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

Patient weight was not available.

Event Description

It was reported that on a follow-up appointment ((b)(6) 2019), that a gore® cardioform septal occluder was discovered to have embolized.It looked to be in the right pulmonary artery.The patient is being assessed for device removal.

Event Description

It was reported that on a follow-up appointment (9/19/2019), that a gore® cardioform septal occluder was discovered to have embolized.It was found to be in the right pulmonary artery.On 10/14/2019, the device was explanted and the defect was surgically repaired.The patient was doing well following the procedure.

Manufacturer Narrative

B5: the event description has been updated.D7: added explant date.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9199351
• MDR Text Key: 162981519
• Report Number: 2017233-2019-01041
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631032
• UDI-Public: 00733132631032
• 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
• Report Date: 11/13/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: GSX0030A
• Device Lot Number: 18423078
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR