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

Model Number 19AHPJ-505

Device Problem Packaging Problem (3007)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 01/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2016, the patient underwent an aortic valve replacement procedure due to native aortic valve stenosis.The aortic valve was resected and pledgeted single sutures were placed though the aortic annulus.An sjm mechanical heart valve sizer set, model 905 was utilized to size the patient's annulus.This 19 mm sjm masters series hemodynamic plus valve was parachuted into the annulus in the anatomic position and it did not fit.It was removed and a manouquian type aortic root enlargement was performed using a dacron graft.A second attempt to implant the valve using single sutures had the same outcome and the valve did not fit into the enlarged root.The manouquian type root enlargement was revised to a nicks type aortic root enlargement and the 19 mm valve was attempted to be placed again with the same outcome.The sjm valve was removed and a 19 mm medtronic valve was implanted.The user reports upon inspection of the 19 mm sjm valve, it appeared that a 21 mm valve had been inadvertently packaged in 19 mm packaging.The procedure time was prolonged and the patient required cpb for 90 minutes.Upon weaning from bypass, a temporary pacemaker was placed.Total procedure time was 7 hours.

Manufacturer Narrative

(b)(4).The results of this investigation concluded the masters series hp mechanical heart valve met dimensional specifications when analyzed at sjm and no anomalies were observed.A review of the device history record confirmed the valve met all visual, dimensional, and functional tests and inspections at the time it was manufactured, prior to shipment.There was no evidence found to suggest there was an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.

• Brand Name: SJM MASTERS SERIES HEMODYNAMIC PLUS 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 ; 6517565400
• MDR Report Key: 5510723
• MDR Text Key: 40687415
• Report Number: 2648612-2016-00022
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2017
• Device Model Number: 19AHPJ-505
• Device Catalogue Number: 19AHPJ-505
• Device Lot Number: 3703613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2012
• 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: 46 YR