MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number E100-29M

Device Problems Device Damaged Prior to Use (2284); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  Injury  

Manufacturer Narrative

The investigation results will be provided in the final report.

Event Description

It was reported that on (b)(6) 2021, the patient underwent surgical explant of their 29 mm epic stented porcine heart valve w/flexfit system.The valve was originally placed (b)(6) 2011 and during that same implant procedure, the patient had a maze procedure performed to treat their atrial fibrillation (afib).During a follow up visit on (b)(6) 2021 it was discovered the patient had developed congestive heart failure symptoms.On (b)(6) 2021 the patient underwent a heart catheterization which revealed valve malfunction, specifically moderate to severe grade mitral stenosis and pulmonary hypertension.On (b)(6) 2021, the patient was transferred to a different hospital for further management.It was at this hospital testing revealed mitral valve regurgitation was caused by the prolapsing of the leaflet during the systolic phase of the patients cardiac cycle.Regurgitation was identified in two locations in the anterior leaflet was detected.These findings lead to the patients need for explant of the 29mm epic stented porcine heart valve w/flexfit system.The device was exchanged with a non-abbott device.The patient remained stable throughout the procedure however it was reported the patient encountered difficulty separating from mechanical ventilation due to bleeding in the lung during procedure.The patient was extubated on (b)(6) 2021.No additional information has been provided.

Manufacturer Narrative

Additional information: d9, g3, g6, h2, h3, h6, h10.Explant of the valve was reported due to mitral regurgitation caused by leaflet prolapse.The investigation found that the valve was received fragmented, with the stent broken in two places and the valve tissue damaged.Cusp 2 and 3 contained probable tears, however due to the state of the returned valve it could not be conclusively determined if the tears were present prior to explant.There was fibrous pannus ingrowth on the outflow surface of the sewing cuff near cusp 3.There were degenerative changes to all three cusps.No inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The degenerative changes to the tissue could have contributed to the suspected tears, and those tears could have contributed to the reported regurgitation, if present prior to explant.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13053282
• MDR Text Key: 283944638
• Report Number: 3001883144-2021-00148
• 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: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2014
• Device Model Number: E100-29M
• Device Lot Number: 3384483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2010
• 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: 84 YR
• Patient Sex: Male
• Patient Weight: 58 KG