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

Model Number E100-27M

Device Problems Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problems Dyspnea (1816); Endocarditis (1834); Mitral Regurgitation (1964)

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

The investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2014, a 27mm epic valve was implanted as part of a double-valve replacement procedure with a competitor's 19mm magna aortic valve.On (b)(6) 2019, the patient developed shortness of breath and severe mitral regurgitation was confirmed.On (b)(6) 2019, the epic valve was explanted and exchanged with a competitor's unknown sized magna mitral ease valve.Upon explant, it was noted that the leaflets were prolapsed and torn.In addition, the physician preoperatively suspected infective endocarditis, however no inflammatory response was noted on the explanted valve.Of note, the patient initially was hospitalized due to shingles on (b)(6) 2019 and was inpatient during onset of shortness of breath.

Event Description

On (b)(6) 2014, a 27mm epic valve was implanted as part of a double-valve replacement procedure with a competitor's 19mm magna aortic valve.On (b)(6) 2019, the patient developed shortness of breath and severe mitral regurgitation was confirmed.On (b)(6) 2019, the epic valve was explanted and exchanged with a competitor's unknown sized magna mitral ease valve.Upon explant, it was noted that the leaflets were prolapsed and torn.In addition, the physician preoperatively suspected infective endocarditis, however no inflammatory response was noted on the explanted valve.Of note, the patient initially was hospitalized due to shingles on (b)(6) 2019 and was inpatient during onset of shortness of breath.

Manufacturer Narrative

Explant was reported due to shortness of breath and mitral regurgitation.The tear seen at explant was confirmed.Cusp 1 was torn and cusp 2 contained a small perforation.Cusp 2 had thinning of the base of the cusp.All three cusps had degenerative changes to the tissue.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 at the time of commercialization.The cause of the tears could not be conclusively determined.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 8842996
• MDR Text Key: 152698545
• Report Number: 3001883144-2019-00070
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 08/23/2019

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: 08/18/2017
• Device Model Number: E100-27M
• Device Catalogue Number: E100-27M
• Device Lot Number: 4444995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 07/30/2019
• Supplement Dates Manufacturer Received: 08/07/2019
• Supplement Dates FDA Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 40