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

Catalog Number GSX0030A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to gore a 30 mm gore® cardioform septal occluder was selected to close an oblong atrial septal defect measuring 14 mm x 6 mm.Echocardiogram performed the following day showed residual shunting.The device was removed with a snare the next day and an amplatzer device was implanted.

Manufacturer Narrative

The engineering evaluation revealed that the size and shape of the occluder and lock loop were unremarkable.The cause of the residual shunt is unknown and cannot be determined from the evidence available.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7552355
• MDR Text Key: 109490736
• Report Number: 2017233-2018-00306
• 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
• Report Date: 05/30/2018

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: 10/30/2019
• Device Catalogue Number: GSX0030A
• Device Lot Number: 17387809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 5 YR
• Patient Weight: 28