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

Model Number	27MECJ-502
Medical Device Problem Codes	Fracture (1260); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2019
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) 2019, a 27mm masters mechanical valve was selected for implant.During the procedure, one of the leaflets broke as the physician was rotating the valve.The patient is recovering.Attempt to obtain additional information were unsuccessful.No further information is available.
Additional Manufacturer Narrative
The reported event of "one of the leaflets broke" was confirmed.Both leaflets were dislodged from the orifice and returned with the valve.No other damage was noted.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 leaflet dislodgment could not be conclusively determined.Please note, per the instructions for use artmt100045600 version a, "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.".
Event or Problem Description
On (b)(6) 2019, a 27mm masters mechanical valve was selected for implant.During the procedure, one of the leaflets broke as the physician was rotating the valve.All pieces were confirmed to be removed.A new 25mm masters valve was successfully implanted.The user does not allege a clinically significant prolonged procedure time and the patient was hemodynamically stable throughout the procedure.The patient is recovering.
Additional Manufacturer Narrative
Corrected information section: h6.
Event or Problem Description
(b)(6) 2019 jl: additional information received on (b)(6) 2019 indicated that pieces of the valve were confirmed to be removed.A 25mm masters valve was successfully implanted.The user does not allege a clinically significant prolonged procedure time and the patient was hemodynamically stable throughout the procedure.On (b)(6) 2019, a 27mm masters mechanical valve was selected for implant.During the procedure, one of the leaflets broke as the physician was rotating the valve.The patient is recovering.Attempt to obtain additional information were unsuccessful.No further information is available.

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED CUFF
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 8981573
• Report Number: 2648612-2019-00071
• Device Sequence Number: 16234401
• Product Code: LWQ
• UDI-Device Identifier: 05414734006453
• UDI-Public: 05414734006453
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2019

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: 03/31/2024
• Device Model Number: 27MECJ-502
• Device Catalogue Number: 27MECJ-502
• Device Lot Number: 6933144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 09/11/2019; 11/01/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 10/08/2019; 11/26/2019
• 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: Required Intervention