MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-500-25

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

The pipeline flex device as not returned for evaluation as it was implanted in the patient.The pipeline flex device performed as intended; as indicated by successful deployment of the device in the intended landing zone to treat an aneurysm located in the internal carotid artery (ica).No device issue was reported during the procedure.Hemorrhage is a known inherent risk of endovascular procedure and is documented in the pipeline flex instruction for use.In addition, the physician stated that there was no causal relationship between the hemorrhage and the pipeline treatment.The cause is unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that 2 days post uneventful pipeline embolization procedure for an unruptured saccular cerebral aneurysm m easuring 16mm located in the internal carotid artery (ica) with a medtronic flow diverter device, the patient developed a hemorrhage distal to the target aneurysm.The distal and proximal landing zone was 4.9mm x 5.2mm.The patient was reported to be in a vegetative state.The patient had dual antiplatelet therapy (dapt) prior to the pipeline treatment and then was not placed on dapt until one week after the procedure.Two days after being placed on dapt, a hemorrhage occurred, and the patient was transferred to the hospital.The detail of treatment provided to the patient during transfer is not available.The physician stated that there was no causal relationship between the hemorrhage and pipeline treatment.The patient is currently symptomatic.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7661518
• MDR Text Key: 113151324
• Report Number: 2029214-2018-00598
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/1999
• Device Model Number: PED-500-25
• Device Lot Number: A232391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2018
• 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): Hospitalization; Life Threatening; Disability
• Patient Age: 82 YR