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

Model Number PED2-500-20

Device Problem Positioning Problem (3009)

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

Event Date 06/18/2019

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported event has not been returned for evaluation; therefore, the event cause could not be determined.Correspondence has been sent out to the customer.Once the device has been received and the investigation has been completed, a supplemental report will be submitted.Reference mdr#: 2029214-2019-00649.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that middle segment of one medtronic flow diverter (5 x 25) did not fully open and another flow diverter (5 x 20) fell into the aneurysm.Prior to the event, the medtronic microcatheter was positioned distal to the aneurysm.An attempt was made to release the first flow diverter (5 x 25) and the reported event occurred.The flow diverter was replaced by another flow diverter (5 x 20) and during maneuvers to release the flow diverter, it fell into the aneurysm.A new flow diverter of the same size was used and implanted successfully.No patient injury was reported as a result of the event.The patient was undergoing embolization treatment of an unruptured saccular aneurysm (unknown measurements) located in the ophthalmic segment of the left internal carotid artery (ica).Patient was on dual antiplatelet therapy.Patient¿s vasculature was severe in tortuosity.No images for review.

Manufacturer Narrative

D10.Device available, return date - additional information.G4.Date manufacturer received - additional information.G7.Type of report - additional information.H2.Follow-up type - additional information.H3.Device evaluation, device returned - additional information.H6.Evaluation codes - additional information, device evaluation.H10.Additional manufacturer narrative - additional information, device evaluation the pipeline flex shield was returned for evaluation.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal ends of the pipeline flex shield braid appeared to be fully opened and moderately frayed.Based on the analysis findings, the pipeline flex shield was not confirmed to have movement during delivery.The event cause could not be determined.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 W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8747171
• MDR Text Key: 149632335
• Report Number: 2029214-2019-00650
• 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: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2020
• Device Model Number: PED2-500-20
• Device Lot Number: A562313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR