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

Model Number 23AHPJ-505

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2019

Event Type  Injury  

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 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.

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 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
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9531333
• MDR Text Key: 173072941
• Report Number: 2648612-2019-00109
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006125
• UDI-Public: 05414734006125
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 12/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention