MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. MASTERS SERIES CAVGJ,AUS TRALIAN,23MM; MASTERS VALVED GRAFT

Model Number	23CAVGJ-514 00
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a 23mm masters valved graft with hemashield technology was selected for implant in a (b)(6) male patient during a bentall procedure.During proximal anastomosis, a suction catheter with a metal tip was used to secure sutures and caused a leaflet of the valve to fracture.All pieces of the fractured leaflet were removed from the patient and the valve was explanted.The procedure was completed with a 25mm masters valved graft with hemashield technology.Per site, procedure and bypass times were significantly extended to revise the conduit and the patient remained hemodynamically stable throughout the procedure.No patient consequences were reported.
Additional Manufacturer Narrative
The reported event of a fractured leaflet was confirmed.One leaflet had dislodged and fractured into multiple pieces.The pivot guard and butterfly apices were also chipped.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported event could not be conclusively determined; however, per the site "a suction catheter with a metal tip was used to secure sutures and caused a leaflet of the valve to fracture".
Event or Problem Description
On (b)(6) 2019, a 23mm masters valved graft with hemashield technology was selected for implant in a 32 year old male patient during a bentall procedure.During proximal anastomosis, a suction catheter with a metal tip was used to secure sutures and caused a leaflet of the valve to fracture.All pieces of the fractured leaflet were removed from the patient and the valve was explanted.The procedure was completed with a 25mm masters valved graft with hemashield technology.Per site, procedure and bypass times were significantly extended to revise the conduit and the patient remained hemodynamically stable throughout the procedure.No patient consequences were reported.Patient's information (e.G.Age, weight, gender, ethnicity, race, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.

• Brand Name: MASTERS SERIES CAVGJ,AUS TRALIAN,23MM
• Common Device Name: MASTERS VALVED GRAFT
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 8463879
• Report Number: 2648612-2019-00021
• Device Sequence Number: 11510574
• Product Code: LWQ
• UDI-Device Identifier: 05414734006149
• UDI-Public: 05414734006149
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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: 04/20/2019
• Device Model Number: 23CAVGJ-514 00
• Device Catalogue Number: 23CAVGJ-514 00
• Device Lot Number: 4574348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 06/05/2019
• 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: 32 YR