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

Model Number PED-450-18

Device Problems Retraction Problem (1536); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2024

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 the ped450-18 stent was delivered in place via the microcatheter phenom27 and was planned to be bridged to the distal end of the first deployed ped425-30.During the deployment process of ped450-18, the second half was repeatedly adjusted and could not be fully opened to adhere to the wall.There was great resistance when trying to retrieve it and it was impossible to retrieve it.During the adjustment process of trying to open the stent, the detachment area of the stent was unloaded.After processing with micro guide wire and micro catheter, the proximal end still could not be fully opened.The pipeline was used for an indication that is approved (on-label).The pipeline and any accessory devices were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm of the right posterior communicating artery segment of the internal carotid artery with a max diameter of 12.31mm and a 7.68mm neck diameter.The landing zone was 4.1mm distally and 4.34mm proximally.It was noted the patient's vessel tortuosity was moderate.Dapt (dual antiplatelet treatment) was administered and the pru level was 0.The angiographic result was normal post procedure.

Manufacturer Narrative

H3: product analysis of ped-450-18, lot no: b584611 found no bend on the pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No other anomalies were observed.Based on the analysis findings, the pipeline flex was not confirmed to have failure to open at the proximal as the pipeline flex braid was not returned for analysis.In addition, the pipeline flex was not confirmed to have resistance as no defect was found with pipeline flex pushwire.The phenom 27 catheter used in this event was not returned.However, the root cause could not be determined.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

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 was received the pipeline not implanted at the intended location and was not opened normally and there were various methods to solve the problem, but it was ineffective; heparin was used during the operation, and xinweining was pumped after the operation.Catheter resistance occurred in the distal section.There was no damage observed to the pipeline pushwire or catheter.The proximal section of the pipeline did not open.The pipeline was placed in a vessel bend when it failed to open.There were additional steps or other devices attempted to open the pipeline.

• 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
• 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: 18485955
• MDR Text Key: 333099299
• Report Number: 2029214-2024-00079
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-450-18
• Device Catalogue Number: PED-450-18
• Device Lot Number: B584611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2023
• 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: 20 YR
• Patient Sex: Male