MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE; HEART-VALVE, MECHANICAL

Model Number	15MHPJ-505
Medical Device Problem Codes	Obstruction of Flow (2423); Biocompatibility (2886)
Health Effect - Clinical Codes	Endocarditis (1834); Low Cardiac Output (2501)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
After mhv implantation on (b)(6) 2019 of a 15mhpj-505 (sn (b)(4)) under compassionate use (before ce mark), it was detected on (b)(6) 2019 a block in one of the leaflets (not moving), after detection of low patient output and increase of gradients.Antithrombotic therapy was introduced without success facing a possible thrombus.The patient wasn't under ac since intervention because of very young age and multiple comorbidities.The patient had been under low molecular weight heparyn.The patient has had lot of concomitant infections due to comorbidities.Surgeons suspect on endocarditis.The prosthesis has been explanted today ((b)(6)) and sent by the surgeons to the microbiology lab at their hospital for analysis.They have implanted another abbott 15mms.
Event or Problem Description
After mhv implantation on (b)(6) 2019 of a 15mhpj-505 (sn (b)(6) ) under compassionate use (before ce mark), it was detected on (b)(6) 2019 a block in one of the leaflets (not moving), after detection of low patient output and increase of gradients.Antitrombotic therapy was introduced without success facing a possible thrombus.The patient wasn¿t under ac since intervention because of very young age and multiple comorbidities.The patient had been under low molecular weight heparyn.The patient has had lot of concomitant infections due to comorbidities.Surgeons suspect on endocarditis.The prosthesis has been explanted today (b)(6) ) and sent by the surgeons to the microbiology lab at their hospital for analysis.They have implanted another abbott 15mms.
Additional Manufacturer Narrative
An event of leaflet immobility and increase of gradient due to possible thrombus in a patient with multiple concomitant infections due to comorbidities and suspected endocarditis was reported.The results of the investigation are inconclusive since the device was not returned for analysis.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.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9557902
• Report Number: 3007113487-2019-00039
• Device Sequence Number: 19394401
• Product Code: LWQ
• UDI-Device Identifier: 05415067016522
• UDI-Public: 05415067016522
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P810002
• 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): 02/18/2020

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: 12/14/2020
• Device Model Number: 15MHPJ-505
• Device Catalogue Number: 15MHPJ-505
• Device Lot Number: 5328893
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/18/2020
• 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