MAUDE Adverse Event Report: PFIZER CO. MITRAL VALVE #25; HEART VALVE MECHANICAL

Device Problem Unintended Movement (3026)

Patient Problem Death (1802)

Event Type  Death  

Event Description

"she had replacement surgery on her heart valves and had to install bjork - shiley #19, mbrp 581 in 1974.On (b)(6) 1985, they were replaced with #23 and #25 over a month at (b)(6) hosp, (b)(6).Her valves were bad and had to be replaced to keep her alive, but couldn't be removed.Her heart was too bad for surgery.Her heart valve was sinking and they couldn't do anything about it.She was taken to the (b)(6) hosp in (b)(6), three times she died, at home 3 times, she suffered so much, but 1985 that seem so bad acts of unk suffering for unk reason where they put them in and they were bad.How would you feel if that was you and had to see her one day suffering and hurting so bad and couldn't do anything to stop it.I have sent papers with this report, may be that will help with what.If there was any law suits or settlement, it didn't seem legally right for anyone to keep from it or any general to keep this that would seem to be unconstitutional.The constitution states that.I called the phone # that the pfizer co gave to see if there was some kind of settlement it seem to be but will not say it sure to be a wrongful death and acts of unk and they could not say the rightful reason or the loss of their loved one.Loved my mother very much i had at times felt like dying, had to suffer for and say this.Because of that had even blackout and was due to that." cardiac risk factors: are significant for positive family history of premature coronary artery disease, dyslipidemia, and a continued tobacco habit of one pack per day.She denies history of hypertension or diabetes.Mitral valve replacement in 1974; aortic valve and mitral valve replacement with bjork-shiley valves in 1985.(b)(6) if not there, i have (b)(6)."did the problem return if the person started taking or using the product again: yes.

• Brand Name: MITRAL VALVE #25
• Type of Device: HEART VALVE MECHANICAL
• Manufacturer (Section D): PFIZER CO.
• MDR Report Key: 6680243
• MDR Text Key: 78958405
• Report Number: MW5070718
• Device Sequence Number: 3
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/19/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: 2017100138
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Disability
• Patient Age: 63 YR
• Patient Weight: 54