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

Model Number 25MJ-501

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficiency, Valvular (1926)

Event Date 07/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2017, a mitral valve replacement was performed and this 25 mm masters series valve was implanted.The intraoperative transesophageal echocardiogram revealed dysfunction of the valve.The aorta was cross clamped and revision of the valve was performed without evidence of any structure limiting the mobility of the valve.The patient was removed again from bypass and dysfunction of the valve remained.Therefore, bypass was reinstituted and the valve was removed and replaced with a larger 27 mm masters series valve (model: 27mj-501, s/n: (b)(4)).Another transesophageal echocardiogram was performed which showed good performance of the replacement valve and no leakage.The procedure was completed without complications.The patient was reported to be recovering.

Manufacturer Narrative

The results of this investigation confirmed both leaflets were fully mobile, and were able to fully open and close.A review of the device history record showed the device met specifications prior to leaving abbott manufacturing facilities.There was no evidence found to suggest the reported event was due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the reported event remains unknown.Information from the field indicated a larger 27 mm masters series valve was implanted.

Event Description

On (b)(6) 2017, a mitral valve replacement was performed and this 25 mm masters series valve was implanted.The intraoperative transesophageal echocardiogram revealed one of the leaflets was immobile due to mechanical obstruction.The aorta was cross clamped and revision of the valve was performed without evidence of any structure limiting the mobility of the valve.The patient was removed again from bypass and dysfunction of the valve remained.Therefore, bypass was reinstituted and the valve was removed and replaced with a larger 27 mm masters series valve (model: 27mj-501, s/n: (b)(4)).Another transesophageal echocardiogram was performed which showed good performance of the replacement valve and no leakage.The procedure was completed without complications.The patient was reported to be recovering.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6784385
• MDR Text Key: 82365575
• Report Number: 2648612-2017-00067
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2022
• Device Model Number: 25MJ-501
• Device Catalogue Number: 25MJ-501
• Device Lot Number: 5829279
• Other Device ID Number: 05414734006354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 8 YR