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

Catalog Number GSX0025A

Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Embolus (1830); Occlusion (1984); Obstruction/Occlusion (2422)

Event Date 07/05/2018

Event Type  Death  

Event Description

It was reported the physician selected a 25mm gore® cardioform septal occluder to close an atrial septal defect balloon sized to 13mm.It was further reported that the device was deployed and repositioned one time prior to lock release.Following lock release, it was reported, device placement was interrogated with transesophageal echocardiography.According to the report, there appeared to be a prolapse of the device on the inferior rim and a decision was made to snare the device.It was further reported that during attempted device retrieval, the occluder prolapsed into the left atrium and embolized to the ascending aorta where it obstructed blood flow.It was reported the patient was placed on extracorporeal membrane oxygenation and expired.

Manufacturer Narrative

Age at time of event is (b)(6).Initially reported as (b)(6).Below is a summary of the findings from the review of electronic files containing digital fluoroscopy and transesophageal echocardiography (tee) that were provided to gore: fluoroscopic imaging made available to gore shows the gore® cardioform septal occluder in its deployed state prior to locking, in both the anterior posterior (ap) and lateral projections.The deployed device in the ap view cannot be assessed due to the tee probe obstructing the view.The lateral view shows two equally sized discs with a separation between the left and right disc indicating appropriate formation of the occluder.Further detailed examination of the deployed occluder in the lateral view cannot confirm whether the entire right disc is on the right side of the septum.Additionally, it is difficult to confirm whether the entire right disc is on the right side of the septum in the fluoroscopic images provided following lock release.Additional fluoroscopic imaging shows the embolized device in the ascending aorta.An angiogram is performed, and the device is shown obstructing flow to the brachiocephalic and left common carotid arteries.Further imaging depicts an angiogram with the device removed and restored perfusion to the brachiocephalic and left common carotid arteries.Transesophageal echocardiographic imaging shows static defect measurements of 9.2 mm in the bicaval view and 12.9 mm in the aortic short axis view.The defect rim measurements are shown as follows: the inferior rim is 14.1 mm, the superior rim is 6.3 mm, and the posterior rim is 12.4 mm.Stop flow balloon sizing is performed and the measurements are recorded as 11.8 mm in the bicaval view and 12.5 mm in the aortic short axis view.Additional transesophageal echocardiographic imaging depicts the assessment of the device stability in the septum.Assessment of the device rims shows no shunting around the device.The delivery catheter is observed in these images, so it is assumed the device has not been released.In additional imaging, the catheter is not observed and it is assumed the device has been released.These images show the device mobile from the septum, and the right disc on the left atrial side on the inferior aspect of the device.The last image depicts the device embolized from the septum and mobile in the mitral valve.Thus, the review of the images provided could not determine a reason for the device embolization; however, the images do confirm the device embolized to the ascending aorta and obstructed blood flow to the brachiocephalic and left common carotid arteries.With regard to a review of manufacturing records associated with this device, the review verified the lot was processed normally and all pre-release specifications were met.In order to mitigate the risk of device embolization, the design of the gore® cardioform septal occluder has several features including the following: platinum-filled nitinol frame engineered for enhanced fluoroscopic and echogenic visibility to allow for the physician to thoroughly assess device positioning during the procedure.The physician has the ability to evaluate the device prior to locking it and may reposition the device by loading it back into the catheter and re-deploying it if necessary.Once the device is deployed and locked the physician can continue to assess the position of the device.If needed, there is still the ability to retrieve it safely.Engineered with a retrieval cord and delivery catheter that allow for the device to be pulled back into the delivery catheter and removed.Additionally, to mitigate the risk of device embolization the gore® cardioform septal occluder instructions for use (ifu) states: the gore® cardioform septal occluder should be used only in conjunction with appropriate imaging techniques to assess the septal anatomy and to visualize the wire frame.Also, to mitigate the risk of device embolization, the ifu additionally addresses device sizing: ¿the defect and atrial chamber size should be evaluated by transesophageal or intracardiac echo with color flow doppler measurement to confirm that there is adequate space to accommodate the selected occluder size without impinging on adjacent cardiac structures (e.G., a-v valves, ostia of the pulmonary veins, coronary sinus, or other critical features).¿ ¿there must be adequate room in the atrial chambers to allow the right and left atrial discs to lie flat against the septum with disc spacing equal to the septal thickness, and without interference with critical cardiac structures or the free wall of the atria.¿ ¿an occluder that pulls through the defect after disc conformation may be too small and should be removed and replaced with a larger size.¿ additionally, a complete section is included in the ifu providing recommended procedures for sizing the defect and selecting the appropriate occluder detailing the imaging required, the need for utilizing stop flow balloon sizing techniques, how to measure the defect size, and the minimum occlude to defect size ratio recommended based upon this information.The ifu lists device embolization as a potential device or procedure-related adverse event.

Manufacturer Narrative

The user facility report (number (b)(4)) was forwarded to gore.This report noted an event date of (b)(6) 2018, which may be the date of death as the case images confirm the procedure date as (b)(6) 2018.The event description provided corresponds with the original report.There is no other new or missing information in the report.Below are the user facility codes and gore's response to whether the type of event represented by the code is addressed in the device labeling.(b)(4).The gore® cardioform septal occluder instructions for use list embolization and death as potential device or procedure related adverse events.(b)(4).The gore® cardioform septal occluder instructions for use address device sizing which covers positioning and device stability ((b)(4)).The instructions for use state: ¿ ¿the defect and atrial chamber size should be evaluated by transesophageal or intracardiac echo with color flow doppler measurement to confirm that there is adequate space to accommodate the selected occluder size without impinging on adjacent cardiac structures (e.G., a-v valves, ostia of the pulmonary veins, coronary sinus, or other critical features).¿ ¿ ¿there must be adequate room in the atrial chambers to allow the right and left atrial discs to lie flat against the septum with disc spacing equal to the septal thickness, and without interference with critical cardiac structures or the free wall of the atria.¿ ¿ ¿an occluder that pulls through the defect after disc conformation may be too small and should be removed and replaced with a larger size.¿ additionally, a complete section is included in the ifu providing recommended procedures for sizing the defect and selecting the appropriate occluder detailing the imaging required, the need for utilizing stop flow balloon sizing techniques, how to measure the defect size, and the minimum occlude to defect size ratio recommended based upon this information.It is unclear how device problem code relates to the reported event; however, the gore® cardioform septal occluder instructions for use address device advancement as follows: ¿ the occluder is delivered using conventional catheter delivery techniques and may be delivered with the aid of a 0.035" guidewire (or smaller), if desired.¿ the gore® cardioform septal occluder should only be used in patients whose vasculature is adequate to accommodate a 10 fr delivery sheath (or 12 fr delivery sheath when a guidewire is used).Additionally, the ifu notes the device is contraindicated for use with anatomy where the gore® cardioform septal occluder size or position would interfere with other intracardiac or intravascular structures, such as cardiac valves or pulmonary veins.

Manufacturer Narrative

Added unique identifier (udi) #.Added an explant date of (b)(6) 2018, according to reviewed case images.Noted the initial reporter also sent report to the fda.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7719000
• MDR Text Key: 114998122
• Report Number: 2017233-2018-00449
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2020
• Device Catalogue Number: GSX0025A
• Device Lot Number: 17768408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 5 YR
• Patient Weight: 17