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

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

Patient Problems Hemorrhage/Bleeding (1888); Loss of Vision (2139); Stenosis (2263); Therapeutic Response, Decreased (2271)

Event Date 02/23/2018

Event Type  Injury  

Manufacturer Narrative

Dodier, p., frischer, j.M., wang, w., auzinger, t., mallouhi, a., serles, w.,.Bavinzski, g.(2018).Immediate flow disruption as a prognostic factor after flow diverter treatment: long-term experience with the pipeline embolization device.World neurosurgery.Doi:10.1016/j.Wneu.2018.02.096 the pipeline devices will not be returned for evaluation as they remain implanted in the patients.Based on the provided information, there does not appear to have been any defect of the devices during use.The events occurred in the patients post-procedure and the causes could not be conclusively determined from the provided information.Mdrs related to this patient: 2029214-2018-00320, 2029214-2018-00321, 2029214-2018-00322, 2029214-2018-00323.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic literature review found reports of patient complications after pipeline placement.The purpose of this article was to report the long-term results after pipeline embolization device (ped) implantation.The authors retrospectively reviewed 40 patients with 59 aneurysms who underwent placement of 54 peds.The patients' mean age was 52.3 years; 34 of the patients were female.The article notes the following early procedure-related complications (<30 days post-procedure): - 1 ipsilateral hemorrhage resulting in poor clinical status (mrs 5) - 1 contralateral hemorrhage - 3 ophthalmoplegia or visual impairment: 2 transient and 1 pre-existing/persisting - 1 asymptomatic in-stent stenosis on follow up angiography.In addition, one patient underwent placement of two peds; later on, a neck remnant was observed and was consequently retreated.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 7449974
• MDR Text Key: 106138801
• Report Number: 2029214-2018-00323
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2018
• 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): Other