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

Model Number PED3-027-550-16

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

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

Event Date 09/02/2021

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 pipeline vantage did not open normally at the distal end: it was really slow.The physician wanted to re-sheath the device for better placement, but the pipeline became stuck/locked-up at the distal and middle sections of the phenom microcatheter.The physician then removed both devices together.It was noted a continuous flush had been administered, and there was no damage to the devices observed.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiographic results were good.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the posterior communicating (pcom) artery with a max diameter of 5 mm and a 3.5 mm neck diameter.It was noted the patient's vessel tortuosity was severe.Dual antiplatelet therapy (dapt) was administered.Ancillary devices include a  rist 107f-079-100,  navien 125 cm, phenom 27.

Event Description

Dditional information received reported the wrong image was sent with original report.Correct image sent.The pipeline was not positioned in the bend when it failed to open.

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.

Manufacturer Narrative

Product analysis: as found condition: the pipeline vantage with shield and the phenom 27 catheter were returned for analysis within shipping box; within sealed primary and secondary plastic bio-pouches.Visual inspection/damage location details: the pushwire was protruding from the hub and the braid was partially deployed from catheter tip.In addition, sleeves and tip coil were deployed from catheter distal tip.The catheter tip, marker band and body were examined; and no damages were found.No flash or voids molded were observed in the hub.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.No bend was observed on the pushwire.The distal and proximal ends of the pipeline vantage with shield were found fully opened and slightly damaged.No defects were found with the tip coil, distal marker, re-sheathing marker, silicone disks or with the proximal bumper.No other anomalies were observed ¿testing/analysis: for further examination, the pipeline vantage with shield was pushed out from the catheter without issues.The total and usable lengths of the catheter were measured to be within specifications.The catheter was flushed with water and water exited out from the distal tip.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub, lumen and tip with no issues.Conclusion: based on the analysis findings, the pipeline vantage with shield was not cofirmed to have failure to open at the distal end.The root cause could not be determined as the distal and proximal ends of the pipeline vantage with shield braid appeared fully opened and slightly frayed.However, the cause for damage could not determine.Possible cause includes patient tortuous anatomy.However, based on the analysis findings, the phenom 27 was not confirmed to have catheter resistance.The root cause could not be determined as no defects were found with the returned catheter.It's possible that the severe vessel tortuosity may have contributed to the catheter resistance.There was no non-conformance to specifications identified that led to the resistance issue.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.

Manufacturer Narrative

Correction: h6 codes were updated based on analysis results; it was noted in an effectiveness check that these codes were not updated when the report was submitted with analysis results on (b)(6) 2021.H3.Product analysis: equipment used: video inspection system (m-78210), ruler 200cm (m-83361), camera (panasonic lumix dmc-zs5) and in-house 0.0265in mandrel as found condition: the pipeline vantage with shield and the phenom 27 catheter were returned for analysis within shipping box; within sealed primary and secondary plastic bio-pouches.Visual inspection/damage location details: the pushwire was protruding from the hub and the braid was partially deployed from catheter tip.In addition, sleeves and tip coil were deployed from catheter distal tip.The catheter tip, marker band and body were examined; and no damages were found.No flash or voids molded were observed in the hub.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.No bend was observed on the pushwire.The distal and proximal ends of the pipeline vantage with shield were found fully opened and slightly damaged.No defects were found with the tip coil, distal marker, re-sheathing marker, silicone disks or with the proximal bumper.No other anomalies were observed.Testing/analysis: for further examination, the pipeline vantage with shield was pushed out from the catheter without issues.The total and usable lengths of the catheter were measured to be within specifications.The catheter was flushed with water and water exited out from the distal tip.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub, lumen and tip with no issues.Conclusion: based on the analysis findings, the pipeline vantage with shield was not confirmed to have failure to open at the distal end.The root cause could not be determined as the distal and proximal ends of the pipeline vantage with shield braid appeared fully opened and slightly frayed.However, the cause for damage could not determine.Possible cause includes patient tortuous anatomy.However, based on the analysis findings, the phenom 27 was not confirmed to have catheter resistance.The root cause could not be determined as no defects were found with the returned catheter.It's possible that the severe vessel tortuosity may have contributed to the catheter resistance.There was no non-conformance to specifications identified that led to the resistance issue.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 VANTAGE WITH 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: 12447674
• MDR Text Key: 270574531
• Report Number: 2029214-2021-01142
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2024
• Device Model Number: PED3-027-550-16
• Device Catalogue Number: PED3-027-550-16
• Device Lot Number: B174734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2021
• 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 Age: 69 YR
• Patient Sex: Female
• Patient Weight: 67 KG