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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REVERSE MEDICAL MICROVASCULAR PLUG; DEVICE, EMBOLIZATION, VASCULAR
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REVERSE MEDICAL MICROVASCULAR PLUG; DEVICE, EMBOLIZATION, VASCULAR Back to Search Results
Model Number MVP-7Q
Medical Device Problem Code Unintended Ejection (1234)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/09/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The microvascular plug device will not be returned for evaluation as it remains in the patient; therefore, no definitive conclusion can be drawn regarding the clinical observation.Per instructions for use (ifu): "do not advance the delivery wire after detaching it from the mvp device." if information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information that mvp-7q was detached prior to the physician intentionally detaching the mvp.No patient injury was reported.
 
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Brand Name
MICROVASCULAR PLUG
Common Device Name
DEVICE, EMBOLIZATION, VASCULAR
Manufacturer (Section D)
REVERSE MEDICAL
13700 alton parkway, ste. 167
irvine CA 92618
MDR Report Key8804570
Report Number3007170829-2019-00005
Device Sequence Number16257706
Product Code KRD
UDI-Device Identifier00847536025431
UDI-Public00847536025431
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K150108
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/18/2019
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? Yes
Operator of Device Health Professional
Device Expiration Date01/28/2021
Device Model NumberMVP-7Q
Device Lot NumberA783329
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/10/2019
Initial Report FDA Received Date07/18/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age20 YR
Patient Weight65
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