MAUDE Adverse Event Report: ST. JUDE MEDICAL CANADA, INC.; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-23A-IDE

Device Problems Material Too Rigid or Stiff (1544); Device Operates Differently Than Expected (2913)

Patient Problems Aortic Regurgitation (1716); Congestive Heart Failure (1783)

Event Date 06/24/2016

Event Type  Injury  

Manufacturer Narrative

Gtin -- unavailable as device was manufactured prior to gtin assignment.

Event Description

On (b)(6) 2009, a 23mm trifecta valve was implanted.On (b)(6) 2016, the patient presented with acute congestive heart failure.Further evaluation showed severe aortic regurgitation secondary to presumed valve deterioration and a flail cusp which led to the valve being explanted the same day.Intraoperatively, the native annulus was debrided and was found to be stiff and noncompliant.A 21mm edwards magna ease valve was implanted.(clinical patient study id: (b)(6)).

Manufacturer Narrative

The results of this investigation concluded tearing was observed in all three cusps, with loss and denaturation of collagen at the tear sites.Circumferential fibrous pannus ingrowth was observed on the inflow side with minimal extension onto cusp 1, and protrusion into the inflow space and mild narrowing of inflow diameter.Cusp 3 was mildly fibrotically thickened.No acute inflammation or significant calcifications was observed.No evidence was found to suggest the cause of the cusp tears, pannus, loss and denaturation of collagen, and fibrous thickening was 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.

• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL CANADA, INC.; 2550 blvd. vanier; st. hyacinthe J2S 6 L7; CA J2S 6L7
• Manufacturer (Section G): ST. JUDE MEDICAL CANADA, INC.; 2550 blvd. vanier; st. hyacinthe J2S 6 L7; CA J2S 6L7
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5783411
• MDR Text Key: 49203158
• Report Number: 8020430-2016-00010
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2009
• Device Model Number: TF-23A-IDE
• Device Catalogue Number: TF-23A-IDE
• Device Lot Number: 2777336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2008
• 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: 64 YR