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

Model Number PED2-500-30

Device Problems Unintended Movement (3026); Physical Resistance/Sticking (4012)

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

Event Date 05/03/2023

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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the catheter moved during deployment and the pipeline became stuck in the distal part of the phenom 27 microcatheter during resheathing.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the c5 segment.The max diameter was 14mm, and the neck diameter was 13.45mm.The patient's vessel tortuosity was normal. dual antiplatelet treatment was not administered.It was reported that when the catheter arrived at the position where the pipeline was expected to release during the operation, the pipeline was brought into the catheter.However, the catheter fell down.During this time pipeline was still in the microcatheter under the angiography.The doctor planned to reposition the microcatheter and also pull the pipeline lower in the microcatheter.At this time the user found that the pipeline could not be retracted or moved forward.The doctor felt that the pipeline was stuck in the microcatheter, so they withdrew the product.The patient was stable and the operation was rescheduled.The physician had released the load/slack in the system, but this did not resolve the issue.There was no damage to the catheter or pushwire. the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).

Event Description

Additional information received reported that the tip of the catheter was not under stress.

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 #705597831: ¿ as found condition: the pipeline flex shield was returned stuck inside the phenom 27 catheter; within the inner pouch; inside of a sealed bio-hazard bag and a shipping box.¿ 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 hypotube appeared 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 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.The catheter tip and marker were examined; no damages were found.The catheter body appeared to be accordioned at 2.6cm to 19.7cm from the distal tip.No flash or voids molded were observed in the hub.No other anomalies were observed.¿ testing/analysis: the pipeline flex shield was pushed out from the catheter lumen with difficulty.The total and usable lengths of the catheter were measured to be within specifications.The catheter was flushed with water and found patent.The catheter was then tested by running an in-house 0.0260¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub with no issues; however, resistance was observed at the damaged locations.¿ conclusion: based on the returned devices, the customer complaint was confirmed as the returned pipeline flex shield was found stuck inside the marksman catheter.From the damages seen on the catheter (accordioning) and hypotube (stretching); it appears there was high force used.It is possibly that these damages occurred when the customer attempted to resheath the pipeline flex shield through the catheter against the resistance.However, the cause of resistance could not be determined.Possible cause includes lack of continuous flush with heparinized saline during procedure.The customer reported that the vessel tortuosity was normal.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: 16882460
• MDR Text Key: 314717271
• Report Number: 2029214-2023-00758
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-500-30
• Device Catalogue Number: PED2-500-30
• Device Lot Number: B300295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female