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

Catalog Number	ASD44A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) #: p050006.(b)(4).The gore® cardioform asd occluder instructions for use note that removal of the occluder should be considered if the selected occluder allows excessive shunting.
Event or Problem Description
It was reported the physician implanted a 44 mm gore® cardioform asd occluder to close an atrial septal defect balloon sized to 26 mm.The evening of the procedure an echocardiogram showed a residual shunt that was not seen following device implant.The physician removed the device in a transcatheter procedure.The defect was not closed and the patient will likely be sent to surgery.
Additional Manufacturer Narrative
Added h.6.Device code 1: 3026.
Additional Manufacturer Narrative
H.6.Results code 1: corrected from 3221 to 213.A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.

• Brand Name: GORE® CARDIOFORM ASD OCCLUDER
• Common Device Name: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9152538
• Report Number: 2017233-2019-00980
• Device Sequence Number: 3146789
• Product Code: MLV
• UDI-Device Identifier: 00733132636518
• UDI-Public: 00733132636518
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2021
• Device Catalogue Number: ASD44A
• Device Lot Number: 18481001A
• 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; Not provided
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 10/03/2019; 10/15/2019
• 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: Hospitalization; Other
• Patient Age: 71 YR