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

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.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL 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 Key: 12404315
• MDR Text Key: 271640943
• Report Number: 2029214-2021-01101
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284145
• UDI-Public: 00763000284145
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2024
• Device Model Number: PED2-350-12
• Device Catalogue Number: PED2-350-12
• Device Lot Number: B181441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 09/01/2021
• Date Device Manufactured: 03/25/2021
• 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): Required Intervention