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

Model Number 21AHPJ-505

Device Problems Migration or Expulsion of Device (1395); Perivalvular Leak (1457); Detachment of Device or Device Component (2907)

Patient Problems Chest Pain (1776); Embolism (1829)

Event Date 11/27/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The results of this investigation concluded resistance was felt when manipulating the remaining intact leaflet.The dislodged leaflet contained a fracture, and one of the recessed pivot areas contained a chip on the inner butterfly apex.Special stains were negative for organisms, and no acute inflammation or significant calcifications were present.The evenness of the coating and unremarkable nature of the material, ruled out any suggestion material defect.Rather, the fractured leaflet and orifice damage was caused by some external force applied to the leaflet and orifice, which overstressed the carbon material.There was no evidence found to suggest the cause of the leaflet fracture, orifice damage, and difficulty opening and closing one leaflet were 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.

Event Description

In (b)(6) 2008, an aortic and mitral valve replacement procedure was performed where a 33 mm sjm mechanical valve was implanted in the mitral position and this 25 mm sjm masters series valve was implanted in the aortic position.In (b)(6) 2014, reoperation for aortic paravalvular leak was performed in (b)(6).In (b)(6) 2014, the patient presented with chest pain and required emergent surgical intervention when fluoroscopy noted a single aortic mechanical valve leaflet.At the explant procedure, it was confirmed the presence of a single aortic mechanical valve leaflet.Further investigation determined the presence of the missing aortic valve leaflet was in the iliac artery.The valve was replaced with a mechanical valve from another manufacturer.The patient was reported to be recovering.

Manufacturer Narrative

(b)(4).

• 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 0072 5
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 0072 5
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4370241
• MDR Text Key: 12799458
• Report Number: 2648612-2014-00058
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2013
• Device Model Number: 21AHPJ-505
• Device Catalogue Number: 21AHPJ-505
• Device Lot Number: 0002622223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2006
• 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: 41 YR
• Patient Weight: 80