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

Model Number PED-425-25

Device Problem No Apparent Adverse Event (3189)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 03/09/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the previous pipeline (pli20) implanted one year prior showed residual aneurysm.A new pipeline (pli10) was implanted, but experienced resistance during delivery.The new pipeline was successfully delivered with a slight incomplete apposition of the distal segment.It was indicated there was difficult placement/positioning.A synchro 14 wire with a j-curve was advanced to the distal segment of the pipeline, and the tip of the wire appeared inside the marksman microcatheter.The marksman was removed from the patient and flushed on the table revealing the distal tip of the wire had fractured at the junction on the weld joint.A microvention septer c balloon was advanced and dilated which successfully completed apposition of the distal segment of the pipeline.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Ancillary devices include a phenom microcatheter, marksman microcatheter, fubuki sheath, microvention balloon, synchro 14 guidewire.

Event Description

Medtronic received additional information: the previously implanted pipeline model and lot numbers are (initial treatment date 4/2/2018) ped-425-25 lot# a251741.Patient information is (lk), dob: 11/16/1962, weight: 70 kg, female.The aneurysm was in left internal carotid artery (ica), ophthalmic segment.Aneurysm 2mmx3mm.The vessel tortuosity was moderate.

Manufacturer Narrative

Updated sections: a(1-4) - patient information b5 - additional event details d4 - device information h4 - manufacture date linked with mdr: 2029214-2020-00310.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9813600
• MDR Text Key: 189866744
• Report Number: 2029214-2020-00210
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2019
• Device Model Number: PED-425-25
• Device Lot Number: A251741
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 70