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

Model Number PED3-027-450-25

Device Problems Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 10/06/2021

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 product was stuck (locked up) in the catheter and there was resistance in the catheter at the distal end during deployment.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right ica (internal carotid artery), opht almic segment with a max diameter of 16mm and a 12mm neck diameter.It was noted the patient's vessel tortuosity was moderate.It was reported that the procedure planned to leave an echelon inside the aneurysm to practice a jailing technique.During the deployment of the device, everything worked properly but when the physician reached the not resheathing marker, they could not continue.They were unable to resheath without and with pushing the pusher.The unload of the whole system occurred, however, the same problem persisted.It seemed that the proximal part of the resheathing mechanism was stuck in the microcatheter.The inr took the microcatheter fixed with the push and they pulled back both together inside the navien.During this process, there was no problem detected so the pipeline and phenom were removed together.The catheter was flushed continuously with heparanized saline.The physician attempted to release the load (slack) in the system in an attempt to resolve the issue, however, it did not resolve the issue.The catheter was not damaged.The pushwire was damaged, however, at the proximal end.The pushwire was damaged due to force transmitted to try to deliver the ped when it became stuck.A shorter ped was implanted to resolve the issue.A dapt (dual antiplatelet treatment) was administered.The pru level was unknown.The angiographic post procedure result was good.The pipeline was used for an approved on label procedure and prepared as indicated in the ifu.There were no patient symptoms or complications associated with this event.Ancillary devices include a navien guide catheter 6f 115cmsynchro with extra support.

Manufacturer Narrative

H3: the pipeline vantage system was returned within phenom-27 catheter.The pipeline vantage was found to be extending ~33.8cm from hub and ~6.8cm from distal tip.The pipeline vantage was then pushed out from catheter for further analysis; however, was unable to be removed due to resistance.The pipeline vantage pushwire was found to be kinked at ~18.9cm from proximal end.The hypotube and ptfe were found to be intact.The a.R.M.(advanced re-sheathing mechanism) was found to be intact.The silicone disks were found to be damaged.The dps sleeves were found to be intact.The tip coil was found to be intact.The proximal braid end was found to be opened and frayed.The distal braid end was found to be opened and appeared to be in good condition.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿lockup/resistance at distal segment of catheter¿ was confirmed.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies.Based on the device analysis and reported information, the customer¿s report of ¿resistance during re-sheathing¿ was unable to be confirmed and the cause for the resistance could not be determined.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ was confirmed; however the root cause could not be determined.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: 12637498
• MDR Text Key: 281990740
• Report Number: 2029214-2021-01279
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED3-027-450-25
• Device Catalogue Number: PED3-027-450-25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 90 KG