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

Model Number PED-375-14

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

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

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the tip coil came off post the pipeline deployment in the phenom 27 catheter.The separated piece was contained in the micro and removed without problem.The pipeline was implanted.It was note that no additional force was felt when removing the device.However, it was stated that the angle of the micro was acute where the tip detached.No patient injury occurred.The vessel anatomy was minimal in tortuosity.The devices were prepared and used per the instructions for use (ifu).This event occurred during the treatment of an unruptured right mca, m1 segment.The aneurysm was saccular with a max and neck diameter of 6mm each.The landing zone was 3.5mm in the distal and proximal.

Manufacturer Narrative

D10: device available for evaluation - additional information g4.Date mfr rec ¿ additional information h2: type of follow up - device evaluation h3: device evaluated by manufacturer- additional information h6: codes updated as received, the pipeline flex pushwire hypotube was found crushed from the proximal end with the ptfe shrink tubing broken at that same location.The distal hypotube was also found broken near the distal end of the ptfe shrink tubing with the shrink tubing found damaged at this location.No stretching was found with the hypotube.The distal broken hypotube, resheathing marker, resheathing pad, distal marker, delivery wire, proximal bumper, tip coil and braid were not returned for analysis.The broken end of the hypotube was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.Sem/eds summary: most of the fracture surfaces exhibit corrosion damage.A few areas exhibit dimple features consistent with ductile overload type failure.Based on the analysis findings, the pipeline flex shield was confirmed to have ¿pushwire break at distal hypotube.¿ it is likely the cause of the break is due to the reported ¿angle of the micro was acute where the tip detached.¿ the customer is likely to have use high force delivery against the resulting resistance causing the hypotube to break.Possible contributors towards failure are patient vessel tortuosity, catheter damage or user re-sheaths more than two times.Customer reported patient vessel tortuosity as minimal.As the distal segment, braid and microcatheter were not returned for analysis, any contribution of the distal segment, braid and microcatheter towards the failure could not be determined.Per our instructions for use (ifu): "discontinue delivery of the device if high force or excessive friction is encountered.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ 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: 9430450
• MDR Text Key: 196142579
• Report Number: 2029214-2019-01208
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015579
• UDI-Public: 00847536015579
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2022
• Device Model Number: PED-375-14
• Device Lot Number: A880363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 03/13/2020
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR