MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, B.V. (CD) SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number 19AGFN-756

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Dyspnea (1816)

Event Date 06/16/2016

Event Type  Injury  

Manufacturer Narrative

Gtin: unavailable due to 2004 manufacturing date.

Event Description

On (b)(6) 2004, this 19mm regent valve was implanted.Per report, the patient recently developed increasing dyspnea and an increased gradient (125 mmhg) with an obstructed leaflet secondary to calcification were observed.A redo procedure was performed on (b)(6) 2016 to explant the valve.During explant, both leaflets dislodged in vivo and one leaflet could not be retrieved and later migrated to the junction between the aorta and iliac artery.The patient is being monitored via ct scans and may require additional surgery to remove the remaining leaflet.A 21mm hancock valve was implanted along with an aortic root enlargement using a haemashield patch graft.

Manufacturer Narrative

(b)(4).The results of this investigation concluded the 19mm sjm regent valve was fractured and the entirety of the valve was not returned to sjm for analysis.It is unknown how or when the damage occurred.There was no evidence of material defect in the carbon coating that may have caused or contributed to the fractured orifice.Rather, the orifice fracture may have been caused by some external force applied to the orifice, which overstressed the carbon material and resulted in the damage.There was fibrous pannus on the sewing cuff.A gram stain was negative for organisms and no inflammation was present.A review of the device history record showed the device met specifications prior to leaving sjm manufacturing facilities.There was no evidence found to suggest there was an intrinsic defect in the valve, as supported by the review of the device history record and by the analysis performed.The cause of the reported event remains unknown.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, B.V. (CD); lot 21; caguas west industrial park; caguas, puerto rico 00726 -099
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, B.V. (CD); lot 21; caguas west industrial park; caguas, puerto rico 00726 -099
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5820542
• MDR Text Key: 50369739
• Report Number: 2648612-2016-00067
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PP810002
• 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: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/22/2009
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: 2902959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2004
• 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): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 76