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

Model Number PED-475-16

Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

See manufacturer report # 2029214-2020-01256 and 2029214-2020-01257 for the reports of the related pipelines used in the procedure.Information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that three pipelines failed to open distally and experienced resistance in the distal segment of the phenom 27 microcatheter.The patient was undergoing treatment for an unruptured, wide-necked, saccular aneurysm located in the right internal carotid artery.The max diameter was 7 mm, and the neck diameter was 4 mm.The landing zone was 4.53 mm distal and 4.78 mm proximal.The patient¿s vessel tortuosity was severe and was said to have a high riding posterior genu.The access vessel was the ica and was 4.78 mm in diameter.It was reported that the phenom 27 microcatheter was advance into the m1 with a degree of difficulty.The first pipeline (4.5 x 20) was attempted to be advance past the aneurysm.The physician experienced a great degree of resistance and eventually navigated into position and began to unsheathe the device.Approximately 50% of the device was unsheathed and the distal tines of the pipeline would not open and appeared to be frayed.The device was removed,and a second attempt was made with a 4.75 x 18 pipeline.The physician encountered resistance and once in position again attempted to deploy the device.The pipeline again opened in the center, but the distal segment remained closed.This device was removed, and a third attempt was made with a 4.75 x 16 pipeline.There was resistance while delivering, and when the device began to unsheathe the distal end remained closed.The physician decided to remove the device and discontinue treatment.The patient will be rescheduled for later date with a different device.The device had not been placed in a bend, and more than 50% had been deployed when it failed to open each time.Two or less resheathing attempts were made, and no additional steps were taken to open the device.The patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).Ancillary devices include a navien 058 guide catheter, stryker cat 5 guide catheter, and synchro 2 guidewire.

Manufacturer Narrative

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.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

Additional information received from a healthcare provider (hcp), via a manufacturing representative (rep), indicated there was no damage to the device or microcatheter upon opening the package.

Event Description

Additional information received from the physician indicated that the push wire was not damaged.However, the distal tines of the device were frayed.

Manufacturer Narrative

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
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10972793
• MDR Text Key: 221532383
• Report Number: 2029214-2020-01258
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00836462015586
• UDI-Public: 00836462015586
• 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: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-475-16
• Device Catalogue Number: PED-475-16
• Device Lot Number: A734804
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR