MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, B.V. REGENT MECHANICAL HEART VALVE WITH SILZONE COATING; HEART-VALVE, MECHANICAL

Model Number CVD0046

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Embolism (1829); Unspecified Infection (1930)

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

Information was received from a medical journal present at the a medical conference for vascular surgery.A 25mm regent mechanical heart valve was implanted on an unknown date.The patient was experiencing swelling and pain and ct imaging was performed and confirmed the ascending aorta left axillary artery bypass had embolized.Abscesses were confirmed around the artificial blood vessel and the artificial blood vessel was removed.A culture was performed and non-typhoid; salmonella o9 group was detected.Antibiotics were prescribed and patient was discharged.No additional information will be received.

Manufacturer Narrative

An event of swelling, pain, the ascending aorta left axillary artery bypass embolization, and abscesses around the blood vessel caused by non-typhoid, salmonella o9 group was reported.The results of the investigation are inconclusive since the device remains implanted was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: REGENT MECHANICAL HEART VALVE WITH SILZONE COATING
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, B.V.; lot 21; caguas west industrial park; caguas, puerto rico 00726 -099
• MDR Report Key: 8811138
• MDR Text Key: 151711436
• Report Number: 3003681312-2019-00004
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CVD0046
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR