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

Model Number PED2-400-12

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/11/2023

Event Type  Injury  

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

Medtronic received a report that during the procedure, the pipeline delivery wire separated at the point of the proximal bumper in the middle section.During the deployment, approximately half of the pipeline was open when the physician felt a change in the resistance of the pusher wire.Under fluro, the physician noticed the pusher wire had fractured at the point of the proximal bumper.The pipeline was not deployed but the pipeline was fully removed along with the phenom 27 catheter.The broken segment was retrieved by a catheter.The physician was able remove all of the pieces of the delivery system.A second device was opened and successfully implanted.The patient was undergoing surgery for treatment of an unruptured aneurysm.Dual antiplatelet therapy (dapt) was administered.The post procedure angiographic result showed that the broken pusher wire was removed with good results.

Manufacturer Narrative

H3: product analysis#: (b)(4): equipment used: video inspection system (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5), in-house 0.026in mandrel drawing(s) referenced: dwgsfg15xxx-yyyy-zz rev.F as found condition: the proximal segment of the pushwire and phenom 27 catheter were returned inside of a sealed bio-hazard bag and a shipping box.The distal broken segment was not returned.Damage location details: the pushwire appeared to be broken at the distal hypotube.The distal hypotube found to be stretched with the ptfe shrink tubing still intact.The distal and proximal ends of the braid were found fully opened and no damage.No bend was observed on the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The catheter tip and marker were examined; no damages were found.The catheter body was found to be accordioned at 8.0cm to 16.3cm from the distal tip.No other anomalies were observed.The broken end of the pushwire was sent out for sem analysis.Testing/analysis: the catheter total and usable length were measured within specifications.The catheter was flushed with water and found patent.The catheter was then tested by running an in-house 0.026¿ mandrel through catheter hub.The mandrel successfully passed through the catheter hub with no issues; however, resistance was observed at the damaged locations.Per the sem results: the broken end failed via ductile overload.Conclusion: based on the analysis findings, the customer complaint was confirmed to have ¿pushwire separation¿ issue as the pushwire was separated at the distal hypotube.The broken end failed via ductile overload.In addition, from the damages seen on the catheter body (accordioning) and hypotube (stretching/separating); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance the pipeline flex shield through the catheter against the resistance.However, the cause for resistance could not be determined.Possible causes of resistance include vessel tortuosity and lack of continuous flush with heparinized saline during delivery.Ls 2023-09-20 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.

• 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
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17715537
• MDR Text Key: 323040939
• Report Number: 2029214-2023-01635
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284329
• UDI-Public: 00763000284329
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-400-12
• Device Catalogue Number: PED2-400-12
• Device Lot Number: B543032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male