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

Model Number	21AECJ-502
Medical Device Problem Codes	Fracture (1260); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a 21mm masters valve was selected.When the valve was implanted and rotated with the recommended valve rotator, the leaflet fractured into two pieces during the rotation of the valve.The valve and pieces were removed and a second 21mm masters valve was used to complete the procedure.The procedure was extended by half an hour, but the patient did not experience any adverse consequences and is stable and discharged.
Additional Manufacturer Narrative
The reported event of a fractured leaflet was confirmed.One leaflet was fractured and dislodged from the orifice, but was not returned to abbott in its entirety.One interior butterfly apex of the dislodged leaflet was chipped.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.There was no evidence of material defect in the carbon coating that may have caused or contributed to the dislodged leaflet or orifice damage.However, the damage was consistent with some external force applied to the valve which overstressed the carbon material.The cause of the reported event remains unknown.Please note, per the instructions for use, (b)(4), "using the valve holder/rotator and an sjm¿ valve holder handle, rotate the valve in situ to the desired position.The valve should rotate freely.If resistance is noted, the valve holder/rotator may not be properly seated in the valve, the valve may not be in the fully closed position, or the valve may be oversized.If the valve does not rotate freely, do not force valve rotation.".

• 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: 7970642
• Report Number: 2648612-2018-00086
• Device Sequence Number: 1739617
• Product Code: LWQ
• UDI-Device Identifier: 05414734053884
• UDI-Public: 05414734053884
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2022
• Device Model Number: 21AECJ-502
• Device Catalogue Number: 21AECJ-502
• Device Lot Number: 5863121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/29/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 01/04/2019
• 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