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

Model Number	PED-300-30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the tip end of the guide wire was broken.The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm in the left vertebral artery with an unknown max diameter and an unknown neck diameter.It was noted the patient's blood flow was unknown and vessel tortuosity was minimal.It was reported that after the ped was deployed, the tip end was normally opened, and the tip end of the guide wire was broken during the recovery and repositioning process.The pushwire was broken, as the tip coil was detached.The broken segment was able to be removed from the patient with the catheter.It was unknown how many times the pushwire was rotated to deploy the pipeline.No friction or difficulty was noted.The pipleine was removed from the patient.The pipeline and the accessory devices were prepared as indicated in the ifu.A dapt (dual antiplatelet treatment) was administered and the pru level was unknown.The angiographic result post procedure showed a slowed down blood flow.The issue was resolved with the explant.Ancillary devices include a phenom 27 microcatheter.
Additional Manufacturer Narrative
H3: a pipeline flex embolization device and segment of an unknown catheter were returned for analysis within a shipping box; within a sealed plastic biohazard pouch and within an opened pipeline flex embolization device inner pouch.Visual inspection/damage location details: the pipeline flex pushwire was found to be kinked at ~109.7cm from proximal end.The hypotube was found to be stretched with ptfe pulled back.The proximal bumper was found to be intact; pad was found to be damaged and re-sheathing marker was found to be intact.The dps restraints/sleeves, tip coil and braid were found to be damaged.Braid end 1 was found to be collapsed and frayed.Braid end 2 was found to be opened and frayed.No other anomalies were observed.The unknown distal segment of the returned catheter was measured to be 0.4cm.No other anomalies were observed.Conclusion based on the device analysis and reported information, the customer¿s report of ¿pushwire break/separation¿ was unable to be confirmed as no breaks or separations were found with the pipeline.Possible contributor towards failure is user re-sheaths more than two times.Customer reported patient vessel tortuosity as minimal.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
• Common Device Name: 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: 12533242
• Report Number: 2029214-2021-01204
• Device Sequence Number: 11086746
• Product Code: OUT
• UDI-Device Identifier: 00847536014916
• UDI-Public: 00847536014916
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/22/2023
• Device Model Number: PED-300-30
• Device Catalogue Number: PED-300-30
• Device Lot Number: B137459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male