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

Catalog Number GSXE0030

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

Patient Problems Endocarditis (1834); Fever (1858); Headache (1880); Pain (1994); Rash (2033)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

The device is currently at the healthcare facility and is undergoing histopathological analysis.Awaiting return of the device.The gore® cardioform septal occluder instructions for use includes but is not limited to the following potential device or procedure-related adverse events associated with the use of the occluder: endocarditis, headache or migraine.

Event Description

It was reported to gore a 30mm gore® cardioform septal occluder was implanted on (b)(6) 2020 to treat a patent foramen ovale with a long channel.The device required repositioning during implant.Within a day of the procedure the patient developed worsening migraine, chest, arm, and leg discomfort, palpitations, slight fever and eventually an exanthema on the trunk and neck.Transthoracic echocardiogram on (b)(6) 2020 showed a 22x17 large vegetation on the right side of the device and trans-oesophageal echocardiogram on (b)(6) 2020 found a thick coating on the device (both on right and left side) and protruding towards the aortic root.C-reactive protein was low, 48-17.The patient was admitted, cultured, started on antibiotics.It was reported the device was explanted on (b)(6) 2020 and the patient is recovering.The device is undergoing histopathological analysis at the facility and at this time the there are no findings of bacteria in the cultures.

Manufacturer Narrative

H6: added health effect impact code.Updated type of investigation testing of actual/suspected device.

Manufacturer Narrative

H6: added conclusion codes h10/11: explant evaluation.The device was returned to gore and an explant evaluation provided the following information: submitted unfixed was a gore® cardioform septal occluder (gso).The right atrial surface of the device was generally devoid of tissue and all visible device biomaterial surfaces were tan brown with multiple holes/ tears in the device material.The right locking hub was visible, but the locking loop was not grossly visible.The waist of the device was similarly tan-brown with disruptions in device material.On the left atrial surface of the device, the outermost disc was largely disrupted and appeared to be in a folded configuration, the locking hub and eyelet were not grossly visible.The frame had five wire discontinuities and there were multiple device material and wire disruptions including portions of the device missing from the returned specimen.The device biomaterial was generally devoid of tissue except scattered flat plaques of friable tan/ brown tissue.Accumulation of biologic material within the discs was scant, allowing them to remain in flattened configuration.Free-floating in the formalin were two tan brown friable tissue fragments.Histopathological examination of two specimens, free-floating tissue fragments and device material from the left atrial surface, was performed.The device was received unfixed which could have hindered interpretation in areas where cellular detail was not preserved.Microscopically, the free-floating tissue fragments and tissue associated with the left disc was consistent with acute thrombus and foreign body giant cells which is normal for a device implanted for 13 days.There was no evidence of infection or unusual inflammation.The device was subjected to an enzymatic digestion process to remove biologic debris.Following digestion, the device was examined for material disruptions with the aid of a stereomicroscope.It was evident a portion of the device had not been returned as the locking hub and paired ends of the cut wires were not present within the returned device specimen.There were multifocal areas of device material disruptions consistent with damage caused by mechanical manipulation (e.G., grasping, pulling, cutting) with surgical instruments (e.G., forceps, scissors, scalpel) likely used during the surgical explant procedure and/ or subsequent histology procedures.Five wire discontinuities were present; each presented with a pinched beveled free edge.Wire discontinuities were consistent with cutting via sharp surgical instrumentation (e.G., scissors).No wear related disruptions were identified.The reported tissue vegetation on right disc and thick coating on both sides were not present on the returned device; therefore, analysis to address this specific concern could not be performed.

• Brand Name: GORE CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11170031
• MDR Text Key: 226793306
• Report Number: 2017233-2021-01602
• 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,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2022
• Device Catalogue Number: GSXE0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Date Manufacturer Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 32 YR