MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 500

Device Problem Noise, Audible (3273)

Patient Problems Stroke/CVA (1770); Muscle Weakness (1967); Pain (1994); Right Ventricular Dysfunction (2054)

Event Date 07/27/2006

Event Type  Injury  

Manufacturer Narrative

The product remains implanted.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

Event Description

Medtronic received information via a patient call to technical services that 6 months post-implant of this mechanical mitral valve to treat mitral valve prolapse, the patient suffered a right hemisphere stroke.The patient was later diagnosed with chronic obstructive pulmonary disease (copd) as the cause of shortness of breath symptoms.The patient reported significant health issues since the stroke (right ventricular dysfunction, severe foot pain, compromised mobility) as well as louder valve noise and recent onset of generalized weakness.The patient reported that the cardiologist indicates the valve is performing within manufacturing specifications.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: OPEN PIVOT MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5345672
• MDR Text Key: 35161013
• Report Number: 3008592544-2015-00051
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/29/2009
• Device Model Number: 500
• Device Catalogue Number: 500DM33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/29/2004
• 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): Other; Disability
• Patient Age: 00043 YR