MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	TF-27A
Medical Device Problem Codes	Backflow (1064); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Aortic Insufficiency (1715)
Date of Event	01/03/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
On (b)(6) 2014, a 27mm trifecta valve was implanted.On (b)(6) 2020, the valve was explanted due to severe aortic insufficiency.It was also reported that the patient passed away on the same day.Additional information was requested, but has not been provided.
Additional Manufacturer Narrative
Explant was reported due to aortic insufficiency.Also reported was that the patient passed away on the same day.The investigation found that all three leaflets contained tears and calcifications.The leaflets also were fibrously thickened.No inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the tears could not be conclusively determined; however, all of the tears were associated with calcifications.
Event or Problem Description
On(b)(6) 2014, a 27mm trifecta valve was implanted.On (b)(6) 2020, the valve was explanted due to severe aortic insufficiency.It was also reported that the patient passed away during explant of the trifecta valve and the user does allege a relationship between the patient passing and the trifecta valve.
Event or Problem Description
On (b)(6) 2014, a 27mm trifecta valve was implanted.In december 2019, the patient reported dyspnea, coughing up pink colored sputum, and general "flu-like" symptoms.An ekg showed cardiac changes and the patient was hospitalized.The patient was reported to be in acute diastolic heart failure and loud aortic murmur.Tee showed moderated to severe aortic valve insufficiency.The trifecta valve was reported to be abnormal as well.The patient was scheduled for av replacement, however developed an upper respiratory infection (uri) and the replacement procedure was delayed.The patient was discharged home with treatment for the uri and was scheduled to return to the hospital in six days.However, the day before the patient was to return to the hospital, the patient awoke with "stroke-like" symptoms and was hospitalized with a left frontal/temporal ischemic stroke.The av procedure was again delayed.On (b)(6) 2020, the valve was explanted due to severe aortic insufficiency.Upon explant, a leaflet tear was observed.A new unknown sized unknown model valve was implanted and the surgical site was closed.It was reported that the patient was unable to be weaned from bypass due to pulmonary edema.Medication therapy failed to solve the issue.A rvad was placed, but despite treatment, the patient passed away.The user does allege a relationship between the patient passing and the trifecta valve.

• Brand Name: SJM TRIFECTA VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9649673
• Report Number: 3008452825-2020-00041
• Device Sequence Number: 19500089
• Product Code: LWR
• UDI-Device Identifier: 05414734052054
• UDI-Public: 05414734052054
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2020
• Report Date (Section F): 02/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/17/2015
• Device Model Number: TF-27A
• Device Catalogue Number: TF-27A
• Device Lot Number: 4285860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Was the Report Sent to FDA?: No
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 02/04/2020; 02/24/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 02/26/2020; 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 156