MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE PRECLUDE® PERICARDIAL MEMBRANE; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Inflammation (1932); Pericardial Effusion (3271)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

Device information was not provided; therefore, an investigation is unable to be performed and a cause of the reported event cannot be determined.The gore® preclude® pericardial membrane instructions for use note that possible adverse reactions may include inflammation, adhesions, fibrous reaction, and cardiac tamponade.

Event Description

The following publication was reviewed: a case of post-pericardiotomy syndrome after extended thymectomy for invasive thymoma on an unknown date a (b)(6)-year-old man presented with a 36x18x25mm mass lesion in the anterior mediastinum detected by chest computed tomography (ct) during follow-up for a thoracic aortic aneurysm.Invasive thymoma was suspected and extended thymectomy was performed through median sternotomy.The tumor was resected.As the tumor partially adhered to the pericardium, the pericardium was partially resected.The pericardial defect site was reconstructed with a gore® preclude® pericardial membrane.Based on histopathological findings, diagnosis of type b3 thymoma was made.Postoperative day (pod) 6, a blood test revealed prolonged inflammatory response with c-reactive protein (crp) 9.47 mg/dl and white blood cells (wbc) 6400/l.Abpc/cva (ampicillin/clavulanic acid) 250 mg x 3 times/day (oral administration) was started.Pod 8, a high fever of 38 degrees celsius, st elevation in many leads on electrocardiography and pericardial effusion with mild elevation of brightness on echocardiography were observed.Considering possibility of infective pericarditis, the antibiotic agent was changed to pipc/taz (piperacillin/tazobactam) 4.5 g x 2 times/day and vcm (vancomycin) (initial dose was 1 g, and then 0.75 g x 1 time/day).Pod 10, pericardial effusion was increased, and postpericardiotomy syndrome was suspected.Colchicine and nsaids (oral administration) were started.However, shivering occurred after administration of colchicine, and the colchicine was stopped.Pod 11, drug nephropathy was suspected, and the nsaids was stopped.Echocardiography showed marked formation of the septal wall in the pericardium, and it was decided to perform surgical pericardial drainage.Pod 15, thoracoscopic pericardial fenestration was performed.The pericardium was fenestrated in 3 places.A drain was implanted in the pericardium and in the left thoracic cavity.The gore-tex sheet used for pericardial reconstruction was also confirmed.An attempt to remove the sheet was made, however, apparent adhesion between the sheet and the back of the sternum with its surrounding area was observed.It seemed to be difficult to remove the sheet safely and removal of the sheet was abandoned.The procedure was completed.After that, gram staining of the pericardial effusion collected during the surgical pericardial drainage was negative and no malignant cells were found.Therefore, it was concluded that a pericarditis caused by the pericardiotomy syndrome was a cause of the pericardial effusion.Psl (methylprednisolone sodium succinate) 125 mg/day was started.Pericardial effusion was reduced, and the fever went down, and crp and wbc normalized.There was no recurrence of pericardial effusion, and psl was gradually decreased to 20 mg/day until pod 45 (from initial procedure) and the patient was discharged from the hospital.Psl was later stopped during outpatient visit.The following discussion was also reported: the mechanism of postpericardiotomy syndrome is not clear.It is said that the autoimmune response is concerned and strong expression of the anti-heart antibody is observed in patients who develop this syndrome.We also considered that the pericardial reconstruction with the gore-tex sheet may have caused inflammatory response in the pericardium and this caused postpericardiotomy syndrome.Fortunately, infective pericarditis was finally excluded after the reoperation based on gram staining and bacterial culture test results.However, at the time of the reoperation when the culture test results was unknown, removal of the prosthesis (the gore-tex sheet in this case) was essential in nature.Therefore, removal of the gore-tex sheet was one of the purposes of reoperation, however, we judged that it was difficult to remove the sheet safely under the left thoracoscope due to obvious adhesion and only pericardial fenestration was performed.

• Brand Name: GORE PRECLUDE® PERICARDIAL MEMBRANE
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 8956620
• MDR Text Key: 161171643
• Report Number: 3007284313-2019-00267
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K012098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• 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): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 60