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

Model Number PED-425-16

Device Problems Break (1069); Unintended Ejection (1234); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

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

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the pipeline became locked up in the distal segment of the phenom 27 microcatheter and became dislodged from the pushwire.The patient was undergoing surgery for treatment of three aneurysms: saccular, unruptured aneurysms in the ica terminus; supraclinoid; and ophthalmic segement.Max diameters were estimated: terminus 5 mm.Superclinoid 4 mm.Opthalmic 7 mm, and neck diameters were estimated: terminus 3.5 mm.Superclinoid 3 mm.Opthalmic 4 mm.It was noted the patient's vessel tortuosity was moderate.It was reported that the first pipeline was implanted covering the left ica terminus and supraclinoid aneurysms.The the physician advanced the phenom 27 catheter through the implanted pipeline, followed by a second pipeline into a straight segment of the m1.The distal 20% of the pipeline (ped) was opened, and then the physician attempted to recapture the ped using varying degrees of force but was unable to.About 10% more of the ped was let out, and then pulled back on the entire system to relax any forward tension.During the next recapture attempt, the ped became dislodged from the pushwire.The physician could freely advance the pushwire without response from the ped.Then the ped was pulled through the vessel into the guide catheter.The ped, pushwire, and phenom 27 were all successfully removed from the patient.There was no visible damage to the pushwire or ped, but an accordion style damage to the distal segment of the catheter.A new phenom 27 and ped were used to complete the procedure with no issue.It was noted prior too ped implantation, the guide catheter was used which moved frequently in a moderately tortuous area between anterior and posterior genus which required frequent repositioning.Ancillary devices include a penumbra benchmark catheter, phenom 27 microcatheter.

Manufacturer Narrative

H6: codes updated h10: correction upon further review found that regarding the pipeline had dislodged from the pushwire means pipeline braid opens prematurely during recapture.There was not any pipeline pushwire broke/separation issue.This would not meet the criteria for a reportable event as this pipeline braid opens prematurely and there was not any damage found on the pushwire after removed from the patient.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.

Manufacturer Narrative

H6: device code c63242 updated to c62973.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.

Event Description

No additional information received.

• 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: 9700354
• MDR Text Key: 189076967
• Report Number: 2029214-2020-00139
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016149
• UDI-Public: 00847536016149
• 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,Followup
• Report Date: 05/29/2020

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: 11/14/2020
• Device Model Number: PED-425-16
• Device Catalogue Number: PED-425-16
• Device Lot Number: A556725
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 02/06/2020; 05/26/2020
• Supplement Dates FDA Received: 03/03/2020; 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR