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

Catalog Number GSXE0030

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Arrhythmia (1721); Fever (1858)

Event Date 01/30/2020

Event Type  Injury  

Manufacturer Narrative

Literature citation: figueras-coll m, sabaté-rotés a, roguera-sopena m, betrián-blasco p.Reversible atrioventricular block after atrial septal defect closure with a gore cardioform septal occluder.Archives of cardiology of mexico 2020;90(1):90-92.Doi: 10.24875/acm.M19000214.[(b)(4)].

Event Description

This information was received through literature article "reversible atrioventricular block after atrial septal defect closure with a gore cardioform septal occluder" available online 30 january 2020 through the archivos de cardiologia de mexico.The article reports the physician implanted a 30mm gore® cardioform septal occluder to close a 13mm x 10mm atrial septal defect with a deficient aortic rim, 8mm tricuspid rim, and a 40mm total septal length.All other rims were suitable for percutaneous closure.No arrhythmias or any degree of av block were observed during or after the procedure.The following day, the patient had a normal ecg and was discharged.Forty-eight hours later, the patient was re-admitted due to fever.The patient tested negative for acute phase markers and a non-infectious origin was suspected.An echocardiogram showed a well-positioned device, however, an ecg revealed first-degree av block together with intermittent runs of second-degree av block mobitz 1.Suspecting that the conduction disturbance was secondary to inflammation caused by the gore® cardioform septal occluder, intravenous steroid therapy with methylprednisolone was initiated.In the following 48 hours, the ecg showed a progressive normalization of pr interval, and a holter recording performed the 4th day evidenced persistent sinus rhythm.The patient was discharged with a descending schedule of oral steroid dosing.Nickel allergy was ruled out with a skin patch test 2 months after steroids discontinuation and during follow-up no av block recurrence was documented.Two years later the patient remains asymptomatic.

• 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: 9867018
• MDR Text Key: 196576948
• Report Number: 2017233-2020-00209
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2020

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 Catalogue Number: GSXE0030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 12 YR