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

Model Number PED-475-25

Device Problems Positioning Failure (1158); Unintended Ejection (1234); Unintended Movement (3026)

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

Event Date 02/13/2023

Event Type  malfunction  

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.

Event Description

Medtronic received a report that the first ped stent was stuck with the microcatheter and the second ped opened prematurely.The patient was undergoing surgery for treatment of an amorphous, unruptured left cavernous sinus aneurysm with a max diameter of 19.34mm and a 8.91mm neck diameter.The landing zone was 4.42mm at the distal end and 4.89mm at the proximal end.It was noted the patient's vessel tortuosity was severe.The access vessel was the femoral artery with 8mm diameter.Dapt (dual antiplatelet treatment) was administered.The pru level was there was double antibodies for one week, aspirin and clopidogrel.The angiographic result post procedure was the intra-aneurysm branches were obvious.No patient symptoms or further complications were reported as a result of this event.It was reported that because the marksman and pipeline were chosen at the beginning, the blood vessels were tortuous and the tension was too large, which caused the marksman to stretch and get stuck with the stent.As a last resort, the whole system could only withdraw.For the second time, phenom27 was used in combination with the pipeline.The blood vessels were tortuous and delivered to the aneurysm opening, and the whole system fell off.In the process of pushing thecatheter to go upper again, the stent could not be put in place.After some efforts, it was found that the stent implant and the entire delivery system were detached when it was about to be put in place, so it had to be withdrawn from the body again.The third time to re-establish the system to complete the operation.The first pipeline had resistance in the distal section of the catheter and the catheter was flushed continuously with heparanized saline.The first pipeline got stuck in the distal section during delivery.The physician released the load in the system to try a nd resolve the issue, but there was no resolution.The distal section of the marksman catheter was damaged, it was kinked.The pushwire was not damaged.The second pipeline opened prematurely; the stent got detached from the delivery system before it was deployed.There was no friction or difficulty during the procedure with the second pipeline.The pushwire was not rotated or pulled back during the procedure.The pipelines were used for an indication that is approved (on-label).The reported devices and any accessory devices were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.Ancillary devices include a cook 6f long sheath.

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

New information was received that the tip of the catheter did not move during deployment of the second pipeline.

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 that the second pipeline did not jump during deployment.

Manufacturer Narrative

H3: product analysis #705460058: equipment used: video inspection system (m-78210), ruler 200cm (m-83361) drawing(s) referenced: fa-55xxx-xxxx rev.Q, as found condition: the pipeline flex embolization device and marksman catheter were returned for analysis within a shipping box; and within a plastic bio-pouch.The pushwire was returned stuck within marksman catheter.Damage location details: the pushwire was returned extending out from the hub.In addition, tip coil was partially deployed from distal tip.No bend was observed 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.The distal and proximal ends of the pipeline flex braid were found fully open and moderately frayed.No damage was found with hub.The catheter body was found to be accordioned from ~9.2cm to ~7.0cm from distal tip.In addition, the catheter body was found to be kinked at ~1.0cm from distal tip.The marksman catheter tip and marker were examined; and no damages were found.No other anomalies were observed.Testing/analysis: for further examination, the pipeline flex 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.An in-house mandrel was inserted into the marksman micro catheter hub and catheter lumen without issues however, resistance was observed at the damaged locations.Conclusion: based on the analysis findings, the pipeline flex and marksman catheter were confirmed to have resistance as the returned pipeline flex was stuck inside the marksman catheter.In addition, the pipeline flex braid and the marksman catheter were found to be damaged.From the damages seen on the catheter body (kinking/ accordioning), pipeline flex braid (fraying); it is likely high force used during the delivery.It is possible these damages occurred when the customer attempted to advance and retrieve the pipeline flex through the marksman catheter against resistance.It's possible that the severe vessel tortuosity may have contributed to the catheter resistance.(nikkhs2 2023-04-19) 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
• 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: 16378549
• MDR Text Key: 309611272
• Report Number: 2029214-2023-00282
• 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,Followup
• Report Date: 04/25/2023

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
• Device Operator: Health Professional
• Device Model Number: PED-475-25
• Device Catalogue Number: PED-475-25
• Device Lot Number: B357796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 02/13/2023; 02/28/2023; 04/20/2023
• Supplement Dates FDA Received: 02/27/2023; 03/02/2023; 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2022
• 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: 57 YR