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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-350-12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 08/07/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the patient had re-hemorrhaged. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right para-opthalmic artery with a max di ameter of 7mm and a 4mm neck diameter. The landing zone was 2. 9mm on the distal end and 3. 4mm on the proximal end. It was noted the patient's vessel tortuosity was minimal. The patient had pipeline shield device to treat right para-ophthalmic aneurysm on (b)(6) 2021. Surgery was successful and post procedure angiogram showed good result. The patient suffered an ich on (b)(6) 2021. The doctor performed a decompression surgery and clot removal. After the surgery the patient re-hemorrhaged. Patient had ischemic stroke a few days post procedure after pipeline. Patient had hemorrhagic conversion this past weekend. The patient is deceased. Dapt (dual antiplatelet treatment) administered and pru level was 130. The pipeline and any accessory devices prepared as indicated in the ifu. Additional information was received from the rep on 2021-aug-24. It was reported that the patient is not deceased. She did bleed and have decompression surgery post pipeline embolization surgery. The doctors is unable to determine the direct cause of the patient¿s hemorrhage. There were no procedure related issues with the patient. The surgery went well during and after the procedure. The patient had underlying medical conditions of hypertension, diabetes, hyperlipidemia, and prior tia. There are no operating reports available per the doctor. After the procedure the patient had distal stroke on ipsilateral side of device placement. Clot was too distal for thrombectomy and patient was placed on a heparin drip. Cta was performed and pipeline device was patent. No thrombus in pipeline. In the next few days she had a hemorrhagic conversion and the doctor performed decompression surgery. Patient was released from the icu and sent to a rehab facility.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12404315
MDR Text Key271640943
Report Number2029214-2021-01101
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED2-350-12
Device Catalogue NumberPED2-350-12
Device Lot NumberB181441
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/25/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/01/2021 Patient Sequence Number: 1
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