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

Model Number PED2-475-25

Device Problems Retraction Problem (1536); Activation Failure (3270)

Patient Problems Neuropathy (1983); Paralysis (1997); Thromboembolism (2654)

Event Date 03/07/2022

Event Type  Injury  

Manufacturer Narrative

See manufacturer report # 2029214-2022-00406 for another device involved in this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that two pipelines failed to open and became stuck in the middle of the phenom microcatheter during removal.The patient was undergoing treatment for aneurysm treatment.The patient's vessel tortuosity was normal.Dual antiplatelet treatment was administered.It was reported that the first pipeline didn't fully open proximally.After several maneuvers to open the device, it was resheathed and got stuck in the catheter in the attempt to be removed.A second pipeline didn't fully open distally, after several maneuvers to open the device it was resheathed and got stuck in the catheter in the attempt to be removed.The microcatheter was entrapped in the guide catheter.No additional surgical or medical interventions were required. the patient experienced thromboembolism causing hemiplegia and neglect.Angiographic results post procedure showed the desired result with the replacement device. the devices were prepared and flushed according to the instructions for use (ifu).

Manufacturer Narrative

H3.Product analysis: the pipeline flex shield was for evaluation inside of a sealed bio-hazard bag and a shipping box.There was no catheter returned with the pipeline flex shield.Visual inspection/damage location details: the distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal end of the braid was not opened due to damaged braid.The proximal end of the braid was found fully opened and frayed.No bend was found on the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.No other anomalies were observed.Conclusion: based on the returned device, the customer complaint was confirmed as the pushwire (hypotube) was found stretched.In addition, the distal end of the braid was not opened due to damaged braid.The damage to the braid on the ends of the pipeline flex shield is likely the results of the physician re-sheathing the device more than recommended two times.From the damages seen on the hypotube (stretching) and the braid (fraying); it appears there was high force used.It is likely these damages occurred when the customer attempted to deliver/retrieve the pipeline flex shield through the phenom catheter against the resistance.However, the root cause could not be determined.Possible cause includes vessel tortuosity.There was no non-conformance to specifications identified that led to the reported issues.Per our instructions for use (ifu), the user should: ¿discontinue delivery of the device if high force or excessive friction is encountered during delivery.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ h6.Coding updated based on analysis results.Associated with devices used in the same event reported in rr#: 2029214-2022-00406, 2029214-2022-00408.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.

Event Description

Additional information received reported the patient underwent a procedure for flow diverter treatment of a symptomatic left cavernous segment internal carotid artery (ica) aneurysm measuring 12x9x9mm.The pipeline was not positioned in a vessel bend.Resheathing was attempted but no other devices or steps were tried.Post-operatively, the patient symptoms included residual paraesthesia in the sole of the foot and mild upper extremity paresis.The patient's symptoms were not to be cause by thromboembolic infarcts.

Manufacturer Narrative

Associated with devices used in the same event reported in rr #: 2029214-2022-00406, 2029214-2022-00408.H6 patient coding updated based on additional information received.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 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: 13764944
• MDR Text Key: 289492459
• Report Number: 2029214-2022-00407
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Followup,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2023
• Device Model Number: PED2-475-25
• Device Catalogue Number: PED2-475-25
• Device Lot Number: B036894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2020
• 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