MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Device Problem Biocompatibility (2886)

Patient Problems Hemorrhage/Bleeding (1888); Pulmonary Edema (2020); Thrombus (2101)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a patient was experiencing acute pulmonary edema 43 months after mechanical valve implant and valve thrombosis was found.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The article "thrombolytic treatment of prosthetic valve thrombosis: a study using urokinase " was reviewed.It was reported that a (b)(6) year old female was implanted with a sjm mitral mechanical valve.43 months post-procedure the patient experienced an acute pulmonary edema(ape) and was diagnosed with prosthetic valve thrombosis(pvt).The patient did not receive adequate anticoagulant therapy when diagnosed with pvt.The patient underwent thrombolytic therapy and was treated with a dose of 5,250,000 iu of urokinase.The treatment was a complete success but the patient did experience urine hemorrhage.The article concluded that urokinase is more convenient and successful in the treatment of pvt.The primary author of the article is feng huang, department of cardiovascular surgery, fujian provincial hospital with the correspondence email of aney0329@163.Com.

• Brand Name: SJM MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; RQ 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; RQ 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10766635
• MDR Text Key: 214100066
• Report Number: 2648612-2020-00113
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 62 YR