MAUDE Adverse Event Report:; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 1730 OTFX

Device Problems Mechanical Problem (1384); Activation Problem (4042)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/30/2020

Event Type malfunction

Event Description

Valve was implanted and removed due to cinch mechanism on valve not deploying as intended.

1 Device was Involved in the Event
Type of Device	PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
MDR Report Key	10479507
MDR Text Key	206556199
Report Number	10479507
Device Sequence Number	1
Product Code	NPU
Combination Product (y/n)	N
Number of Events Reported	1
Summary Report (Y/N)	N
Report Source	User Facility
Reporter Occupation	Other Health Care Professional
Type of Report	Initial
Report Date	07/07/2020
1 Patient was Involved in the Event
Date FDA Received	09/01/2020
Is this an Adverse Event Report?	No
Is this a Product Problem Report?	Yes
Device Operator	Health Professional
Device Model Number	1730 OTFX
Was Device Available for Evaluation?	Device Returned to Manufacturer
Date Returned to Manufacturer	06/30/2020
Is the Reporter a Health Professional?	Yes
Was the Report Sent to FDA?	Yes
Date Report Sent to FDA	07/07/2020
Event Location	Hospital
Date Report to Manufacturer	09/01/2020
Type of Device Usage	N
Patient Sequence Number	1
Patient Age	26645 DA
Patient Weight	47