MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM AORTIC VALVED GRAFT (UNKNOWN); MECHANICAL VALVED GRAFT

Device Problem Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A few days after the mechanical valve conduit was implanted (date unknown), the patient developed hemodynamic issues.The aorta was re-opened and the device was rotated using a holder from a sjm masters series valve and the issues were resolved.The conduit remains implanted.

Manufacturer Narrative

Gtin number: unknown since the serial number has not been provided.

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM AORTIC VALVED GRAFT (UNKNOWN)
• Type of Device: MECHANICAL VALVED GRAFT
• 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: 4596344
• MDR Text Key: 5448166
• Report Number: 2648612-2015-00006
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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