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

Model Number E100-29M

Device Problems Material Perforation (2205); Material Split, Cut or Torn (4008)

Patient Problems Dyspnea (1816); Mitral Regurgitation (1964)

Event Date 07/02/2019

Event Type  Injury  

Event Description

On (b)(6) 2014, a 29mm epic valve was implanted in a (b)(6) patient.In (b)(6) 2019, 3 moths ago, the patient presented for a follow-up visit and no anomalies presented.Two weeks ago, the patient presented to the hospital with complaints of dyspnea and a regurgitation sound.An examination revealed mitral regurgitation.Only (b)(6) 2019, a redo mvr was performed and the device was explanted.Upon explant, a leaflet perforation, thinning of the tissue, and tear at the commissure was observed causing the regurgitation.The device was replaced with a 27mm epic valve.No thrombus or calcification was observed on the device.The patient remained hemodynamically.

Manufacturer Narrative

The explant was reported due to regurgitation.The tear, thinning and perforation seen at explant were confirmed.Cusps 1 and 3 were torn.All three cusps were thinning and had loss of collagen.There was fibrous pannus ingrowth on the outflow surface of cusps 1 and 2.No acute 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 at the time of commercialization.The cause of the tears, pannus, and thinning could not be conclusively determined; however, the fibrous pannus ingrowth noted had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tears and reduced durability.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 8837869
• MDR Text Key: 152535001
• Report Number: 3001883144-2019-00072
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

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 Expiration Date: 05/20/2018
• Device Model Number: E100-29M
• Device Catalogue Number: E100-29M
• Device Lot Number: 4665775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 08/20/2019
• Supplement Dates FDA Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 95 YR