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

Device Problems Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Hemorrhage/Bleeding (1888); Vascular Dissection (3160); Insufficient Information (4580)

Event Date 03/09/2021

Event Type  Death  

Manufacturer Narrative

Patient identifier: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Device evaluated by mfr: review of the manufacturing records could not be performed as a valid lot number was not provided.Engineering evaluation could not be performed as the device was discarded.(b)(4).

Event Description

It was reported to gore a gore¿ cardioform septal occluder was selected for a patent foramen ovale (pfo) closure.The shape of the pfo was challenging but the device was successfully implanted.It was then reported that the device had embolized.

Manufacturer Narrative

The date of incident is unknown, therefore, the date ((b)(6), 2021) when the manufacturer was first aware of the incident is used as date of the event.Patient death was reported to w.L.Gore on friday (b)(6), 2021.

Event Description

It was reported to gore a gore® cardioform septal occluder was selected for an emergency patent foramen ovale (pfo) closure.The patient presented with a clinical stroke, profound hypoxia and was tubed and ventilated for refractory hypoxia and agitation.Bedside echocardiogram showed a very prominent aorta with a dilated aortic root.Bubble contrast study was positive for a right to left shunt as the cause of hypoxia and stroke.He failed extubation in icu due to refractory hypoxia (platypnea-orthodeoxia syndrome).The patient was turned down for avr and aortic repair with pfo closure by the cardiac surgeons and came for emergency pfo closure.Tee showed a very abnormal septum.The anterior-posterior distance was small due to the dilated aortic root and the aorta was large and pulsatile.This led to profound distortion of the septal anatomy.Two competitor occluder devices failed the pfo closure, were one of them embolized and and was snared.The gore® cardioform septal occluder initially was deployed successfully with good deployment stability.Unfortunatelly, due to the pulsatility of the dilated aortic root, it led to device embolization to the dilated descending aorta.The retrieval attempted with a snare ultimately led to a linear tear in the aorta with interaction of the device/snare and abnormal aorta leading to a dissection and life threatening bleed.This was treated by an aortic occlusion balloon and emergency vascular retrieval and repair of an approximately 3cm tear.The icu recovery was unfortunately complicated by a recurrent clinically large stroke due to persistent right to left shunting and this together with the vascular injury led to death.The physician reported that the patient's anatomy is extremely challenging and may not be suitable for device closure.However, no other options were presented.

• 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: 11950931
• MDR Text Key: 254657324
• Report Number: 2017233-2021-02063
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention