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

Model Number PED-425-12

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

The proximal segment of the pipeline flex pushwire returned within the inner pouch; inside of a biohazard plastic bag and a shipping box.The distal segment of the pushwire (along with the tip coil, sleeves, resheathing marker, resheathing pad, proximal bumper and the pipeline flex braid) was not returned.The pushwire appeared to be separated at the distal hypotube.The distal hypotube was not stretched.The outer jacket on the distal hyotube was slightly pulled back at ~0.5cm from the broken end.No bend was found on the pushwire.No other anomalies were observed.Based on the returned device, the pipeline flex pushwire was confirmed to have separation at the distal hypotube.Per the sem/eds analysis, approximately half of the fracture surface exhibits dimple features consistent with ductile overload failure mechanism.The rest fracture surface exhibits corrosion damage that obscured the original fracture features.Mdrs related to this event: 2029214-2019-01173 2029214-2019-01174 2029214-2019-01175.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report of pipeline flex pushwire separation during a procedure.The patient was undergoing treatment of a left ica, unruptured, saccular aneurysm.The distal landing zone was 3.7mm and the proximal was 4.1mm.The vessel tortuosity was minimal.The devices were prepared and used per the instructions for use (ifu).The catheter was flushed per the ifu.The pipeline flex braid was deployed without issue.During recapture of the delivery system, the proximal bumper was positioned close to the posterior genu and as the microcatheter was advanced, there was a noted separation of the delivery wire at the proximal bumper.When this was noted, the proximal section of the delivery wire was removed, leaving the distal portion in the vessel.Attempts were made to capture the distal wire with several snares without success.The final decision was to deploy two stents across the entire length of the free wire.

• 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
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9386354
• MDR Text Key: 168771711
• Report Number: 2029214-2019-01173
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016088
• UDI-Public: 00847536016088
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2022
• Device Model Number: PED-425-12
• Device Lot Number: A869900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2019
• 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): Required Intervention
• Patient Age: 63 YR