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

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

Patient Problems Infarction, Cerebral (1771); Intracranial Hemorrhage (1891); Therapeutic Response, Decreased (2271)

Event Date 07/07/2018

Event Type  Injury  

Manufacturer Narrative

Bhogal, p., chudyk, j., bleise, c., lylyk, i., perez, n., henkes, h., <(>&<)> lylyk, p.(2018).The use of flow diversion in vessels =2.5 mm in diameter¿a single-center experience.World neurosurgery, 118.Doi:10.1016/j.Wneu.2018.06.245 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 article: 2029214-2018-00933, 2029214-2018-00934.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic literature review found reports of post-procedure complications after pipeline implantation.The purpose of this article was to review the use of flow diversion on vessels less than or equal to 2.5mm in diameter.The authors retrospectively reviewed patient data and identified 29 patients (22 female, 7 male) with an average age of 56 years who underwent flow diversion treatment of aneurysms.The article notes the following outcomes of pipeline patients: - patient 3 ((b)(6) female) underwent placement of a pipeline 3x16 in the treatment of a saccular aneurysm in the left a1-a2.The patient experienced a frontal lobe hemorrhage.The patient did not require decompressive craniotomy and made a good recovery.- patient 5 ((b)(6) female) underwent placement of a pipeline 3x20 in the treatment of a fusiform aneurysm in the right p2-p3.Sometime post-procedure, the patient underwent retreatment in which additional flow diverters were placed in a telescoping manner.- patient 6 ((b)(6), female) underwent placement of a pipeline 3x16 in the treatment of a fusiform aneurysm in the left p2-p3.Sometime post-procedure, small infarction was seen on follow-up imaging; the patient made a good recovery and had an mrs of 0 at 90 days.In addition, the patient underwent retreatment sometime post-procedure in which additional flow diverters were placed in a telescoping manner.- patient 11 ((b)(6), female) underwent placement of two pipeline devices (3x18, 3.25x18) in the treatment of a fusiform aneurysm in the right mca bifurcation.Sometime post-procedure, small infarction was seen on follow-up imaging; the patient made a good recovery and had an mrs of 0 at 90 days.In addition, the patient underwent retreatment sometime post-procedure in which additional flow diverters were placed in a telescoping manner.

• Brand Name: PIPELINE 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: 8061840
• MDR Text Key: 126917413
• Report Number: 2029214-2018-00934
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100018.S004
• 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: 11/12/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/12/2018
• 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