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 Death (1802); Hemorrhage, Cerebral (1889); Therapeutic Response, Decreased (2271)

Event Date 07/07/2018

Event Type  Death  

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 device will not be returned for evaluation as it was implanted in the patient.Based on the reported information, there does not appear to have been any defect of the device during use.The event occurred in the patient post-procedure and its cause could not be conclusively determined from the reported 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 9 ((b)(6), male) underwent placement of a pipeline 3x20 (pli 20) n the treatment of a dissecting aneurysm in the right mca bifurcation.The patient had worsening symptoms of compression and therefore underwent retreatment; however, the patient had a hemorrhagic stroke, which led to death.

• 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: 8061839
• MDR Text Key: 126882302
• Report Number: 2029214-2018-00933
• 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

• Date FDA Received: 11/12/2018
• 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: 10/18/2018
• 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): Death