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

Model Number	23AHPJ-505
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.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 23 mm master mechanical heart valve was selected for implant.However, when they put in the valve, the leaflets would not move when tested.No tissue was reported to be obstructing the valve.In addition, it was reported that the valve was cracked and it is suspected that the crack happened upon explant.The site sent an individual to a hospital down the street to obtain a new valve.The patient remained on the table and on bypass while the individual retrieved the new valve.There was a prolonged procedure time by 25-30 minutes.A new 23 mm masters mechanical heart valve was successfully implanted.No patient consequences were reported.
Additional Manufacturer Narrative
The reported event of a cracked valve was confirmed.The bottom orifice rim contained a small chip.No other damage was noted.Both leaflets were properly inserted into the orifice and moved freely.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.
Event or Problem Description
On (b)(6) 2019, a 23mm master mechanical heart valve was selected for implant.However, when they put in the valve, the leaflets would not move when tested.No tissue was reported to be obstructing the valve.In addition, it was reported that the valve was cracked and it is suspected that the crack happened upon explant.The site sent an individual to a hospital down the street to obtain a new valve.The patient remained on the table and on bypass while the individual retrieved the new valve.There was a prolonged procedure time by 25-30 minutes.A new 23mm masters mechanical heart valve was successfully implanted.No patient consequences were reported.

• Brand Name: SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9531333
• Report Number: 2648612-2019-00109
• Device Sequence Number: 2651214
• Product Code: LWQ
• UDI-Device Identifier: 05414734006125
• UDI-Public: 05414734006125
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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
• Report Date (Section B): 01/07/2020

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: 04/06/2024
• Device Model Number: 23AHPJ-505
• Device Catalogue Number: 23AHPJ-505
• Device Lot Number: 6941169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 12/24/2019
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 01/07/2020
• 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