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

Model Number PED-475-12

Device Problems Material Deformation (2976); Activation Failure (3270)

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

Event Date 06/03/2021

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 one pipeline experienced resistance in the hub of the phenom 27 microcatheter, two pipelines deployed in the catheter hub, and a third failed to open distally and broke during retrieval.The patient was undergoing flow diversion treatment for an unruptured, saccular aneurysm located in the left ica.The max diameter was 2.9mm, and the neck diameter was 1.5mm.The patient's vessel tortuosity was normal.The landing zone was was 3.5mm distal and 4.5mm proximal.The access vessel was the left ica, which was 3.5-4.5mm in diameter.It was reported that the first pipeline (4.5x10) was inserted into the first phenom 27 catheter and deployed in the hub during insertion.The device was removed.A second pipeline (4.75x10) was inserted into the catheter with extra precaution.This device had resistance in the catheter hub and also deployed in hub.The tip of the sheath had been seated securely in the hub.The second pipeline was removed along with phenom 27 catheter which was replaced with a new phenom 27.A third pipeline (4.75x12) was inserted into the catheter and was able to be introduced into catheter.During deployment of this pipeline, the device would not open distally and had to be retrieved.The middle part of the pipeline had been positioned in a bend, and more than 50% had been deployed when it failed to open.The pipeline had been resheathed 2 or less times, and no further steps were taken to open the device.The third pipeline was removed back into introducer hub; however, unknown at the time, the 4.75x12 pipeline had broken at the proximal bumper during retrieval.A fourth pipeline (4.25x12) was introduced into the catheter.As device was being advanced, fluoro showed the tip of the third pipeline still inside the distal end of the phenom 27.The fourth pipeline 4.25x12 was removed, and the phenom 27 was then removed with the third 4.75x12 pipeline still inside.A new phenom 27 was then placed back in position.A fifth pipeline (4.25x10) was then introduced into catheter.This device was able to be deployed safely and angiographically looked well apposed with good aneurysm stasis. 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 penumbra 8fr neuron max sheath, navien 058 guide catheter, and phenox portal 014 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.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

Additional information received reported that there was no damage observed to the catheter or pushwire.

Manufacturer Narrative

Device analysis: as found condition: the devices were returned for analysis within a shipping box, within a tyvek bio-pouch, and within primary and secondary plastic bio-pouches.The pipeline flex pusher distal hypotube was found broken proximal to the bumper.The pipeline flex braid proximal and distal ends were found open, but damaged (frayed).Dried blood was noted on the braid, ptfe sleeves, and tip coil.The remaining pusher was not returned.The pipeline flex pusher distal hypotube was sent out for sem and eds (energy dispersive spectroscopy) analysis.The hypotube fracture surface exhibits corrosion damage.Dimple features indicative of bending/shear overload are visible on the fracture.Conclusion: based on the device analysis and reported information, the customer¿s ¿failure/incomplete open¿ report could not be confirmed as the device has been fully deployed and re-sheathed.In addition, the pipeline flex braid was found open.It is possible the damage found with the pipeline flex braid and the placement of the braid at a bend contributed to the event; however, the root cause could not be determined.Regarding the pipeline flex¿s pusher separation issue, the customer¿s report was confirmed.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.Based on the formal investigation conducted, pusher separation can occur due to certain use conditions such as excessive force and patient vessel tortuosity.The patient¿s vessel tortuosity was ¿normal¿.However, the remaining pusher was not returned; therefore, any contributing factors could not be assessed.No defect was found with the phenom 27 catheter that would have contributed to the event.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: 11963139
• MDR Text Key: 255419246
• Report Number: 2029214-2021-00702
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016620
• UDI-Public: 00847536016620
• 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: 09/29/2021

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: 09/20/2022
• Device Model Number: PED-475-12
• Device Catalogue Number: PED-475-12
• Device Lot Number: A902100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/08/2021
• Supplement Dates Manufacturer Received: 06/18/2021; 09/24/2021
• Supplement Dates FDA Received: 07/09/2021; 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR