MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC¿ VALVE (MITRAL); HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number E100-25M

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

Patient Problems Stroke/CVA (1770); Cardiac Tamponade (2226)

Event Date 10/03/2023

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional e100-27m device referenced in b5 is filed under separate medwatch report number: (b)(4).

Event Description

It was reported that on (b)(6) 2023, a 27mm epic valve was chosen for implant.Prior to procedure on (b)(6) 2023, the patient presented with severe mitral regurgitation (mr) due to prolapse of the middle posterior (p2) leaflet, mitral annular calcification (mac), and chronic obstructive pulmonary disease (copd).It was reported prior to mitral valve replacement procedure on (b)(6) 2023, mitral valve repair (mitral valvuloplasty) was attempted with a non-abbott ring on the same day.However, the regurgitation could not be controlled and a decision was made to perform a mitral valve replacement with the 27mm epic valve.Due to presence of mac, the calcified part was excised and a patch was implanted to strengthen the left ventricular wall before the 27mm epic valve was implanted.Approximately 6 hours post-procedure, the patient's left ventricle had ruptured and a decision was made to perform mitral valve repair annular reconstruction with a patch and redo the mitral valve replacement.It was reported the patient had not been removed from bypass prior to the left ventricular rupture.It was reported the 27mm epic valve was explanted and replaced with a 25mm epic valve.The procedure was reported to have taken a long time and the patient was returned to the intensive care unit (icu) with catecholamine and intra-aortic balloon pump (iabp).It was reported on (b)(6) 2023, the patient presented with cardiac tamponade and the patient was returned to the operating room for thoracotomy as the heart had been swollen "for the purpose of creating space".The patient's left pupil was dilated and head computed tomography (ct) revealed cerebral infarction, midline shift in the left cerebral hemisphere, and brain herniation.It was determined at that time lifesaving was difficult and do not attempt resuscitation (dnar) policy was taken.It was reported that on (b)(6) 2023, the swan-ganz catheter was removed.It was then reported on (b)(6) 2023, the patient passed away with cause of death as extensive cerebral infarction.

Manufacturer Narrative

An event of patient death three days after the implant procedure was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated the physician thought that there was no problem with the epic valve.The event was reviewed by abbott medical affairs which found that the cause of death was extensive cerebral infarction which was procedure-related due to the need of multiple long procedures in a patient with mitral annular calcification requiring debridement at the time of mitral valve replacement and reoperation due to a ruptured left ventricle.Cerebral infarction is a known potential complication following cardiac surgery with an increased likelihood in the presence of multiple prolonged procedures and cardiac tamponade with a low cardiac output state.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: EPIC¿ VALVE (MITRAL)
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18035020
• MDR Text Key: 326903856
• Report Number: 2135147-2023-04778
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

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: E100-25M
• Device Lot Number: 180665613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 58 KG