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

Model Number	E100-27M-00
Medical Device Problem Codes	Backflow (1064); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Dyspnea (1816); Hypoxia (1918); Mitral Regurgitation (1964)
Date of Event	11/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2020, a 27mm epic stented mitral heart valve was implanted.On (b)(6) 2020, the patient presented to outside hospital with dyspnea and was found to be in hypoxic respiratory failure required intubation.The patient was subsequently transferred to the hospital.The valve was evaluated and it was determined that the valve had failed, further described as "dehiscence of the prosthesis, severe mitral valve regurgitation," and required replacement.The patient status was reported as unknown.Additional information was requested, however was unavailable.
Additional Manufacturer Narrative
Additional information sections: h2, h6, h10.An event of dyspnea, hypoxic respiratory failure, severe mitral regurgitation, and "dehiscence of the prosthesis" was reported.A more comprehensive assessment could not be performed as the device remains implanted was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 10864017
• Report Number: 3001883144-2020-00110
• Device Sequence Number: 3802951
• Product Code: LWR
• UDI-Device Identifier: 05414734055574
• UDI-Public: 05414734055574
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2024
• Device Model Number: E100-27M-00
• Device Catalogue Number: E100-27M-00
• Device Lot Number: BR00023947
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention