MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL

Model Number	19AECJ-502
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A 19mm masters series valve was chosen for implant in the aortic annulus.After the valve was implanted, two attempts were made to attach the holder handler to rotate the valve; however, due to the administration of cardioplegia a view of the surgical field was lost.Attempts to rotate the valve were abandoned and closure of the aortotomy began.When the surgical field was clear of blood, one of the valve leaflets was observed to be split in half.The two pieces were removed from the left coronary sinus, the valve explanted, and a second 19mm masters series valve was implanted.Although no adverse patient consequences were reported, the procedure time was extended beyond 30 minutes.
Additional Manufacturer Narrative
The reported event of a fractured leaflet was confirmed.Gross morphological examination revealed the leaflet had fractured, with a portion between the leaflet's two ears remaining properly inserted into the recessed pivot areas.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown; however, it is consistent with an external force applied to the leaflet and orifice, which overstressed the carbon material and resulted in the damage.

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED CUFF
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 7660654
• Report Number: 2648612-2018-00048
• Device Sequence Number: 1758994
• Product Code: LWQ
• UDI-Device Identifier: 05414734053877
• UDI-Public: 05414734053877
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2022
• Device Model Number: 19AECJ-502
• Device Catalogue Number: 19AECJ-502
• Device Lot Number: 6024207
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 08/27/2018
• 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: Other
• Patient Age: 64 YR
• Patient Weight: 67