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

Model Number PED-500-35

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received report that an abnormal noise was received / heard/ felt during the pipeline flex with shield (ped2) deployment, and the delivery system broke.The ped2 device was resheathed 3 times.When checking the device after retrieval, it was found that the device was broken at the proximal marker, in addition, microcatheter was extended slightly.A same size pipeline with the same lot number was used.However, the replacement device was unable to be deployed as it was noted to be damaged and was retrieved.No patient injury occurred.The patient was undergoing treatment of an ic-pcom, unruptured, saccular aneurysm.The max diameter was 15mm and the neck was 14mm.The distal landing zone was 3.8mm and the proximal was 4.8mm.The anatomy was severe in tortuosity.The access vessel was the ica and was 2.8-5.4mm in diameter.The devices were prepared and used per the instructions for use (ifu).The catheter was hydrated as per the ifu.

Manufacturer Narrative

Codes updated the device was returned for evaluation and the clinical observation was confirmed.As received, the pipeline flex pushwire appeared to be separated at the distal hypotube.The distal segment of the pushwire along with the tip coil, sleeves, resheathing pad and proximal bumper was not returned.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The outer jacket was pulled back from the broken end.Corrosion was observed on the distal hypotube.Kinks and bends were observed on the pushwire from the proximal end.The ends of the pipeline flex shield braid were found fully opened and frayed.The broken end was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) analysis.Based sem/eds and analysis findings, the returned pushwire was found to be separated at the distal hypotube.Most of the fracture surface exhibits corrosion damage that obscured the original fracture features.Only few areas exhibit dimple features consistent with ductile overload failure mechanism.In addition, the pushwire and catheter were also found to be damaged.From the damages seen on the pushwire (kinking/bending/ separating), pipeline flex shield (fraying) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance/retrieve the pipeline flex shield through the catheter against resistance.It is likely that the severe vessel tortuosity have contributed to the resistance during delivery; subsequently causing the pushwire to separate.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9304407
• MDR Text Key: 208994480
• Report Number: 2029214-2019-01116
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-500-35
• Device Lot Number: A848263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1