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

Model Number PED2-400-14

Device Problems Break (1069); Unintended Ejection (1234); Retraction Problem (1536); Physical Resistance/Sticking (4012)

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

Event Date 10/12/2022

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.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

Medtronic received a report that the phenom 27 catheter was in position to prep, flush, and introduce pipeline shield.When the plastic sheath of the pipeline was hubbed into phenom 27, the device would not advance forward.Resistance caused the plastic sheath to back out, causing the pipeline to deploy in the rh valve (touhey).A second pipeline was opened and had the same issue; the device advanced shortly and then had resistance.Recapturing the pipeline back into the plastic sheath was attempted, a lot of resistance was felt, and the distal end of the delivery system snapped off inside the phenom 27.This phenom 27 was removed and replaced with another phenom 27.A new pipeline was opened, prepped, advanced, and implanted with no issue. catheter resistance occurred at the hub.The tip of the sheath seated securely in the hub.There was a catheter leak at the hub.There was force applied while connecting the y connector or syringe to the catheter hub.The catheter was inspected/tested prior to use.The leak was observed during use. the reported devices and any accessory devices were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.  the pipelines were used for an indication that is approved (on-label).No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, unruptured left ophthalmic aneurysm with a max diameter of 4 mm and a 4 mm neck diameter.The landing zone was 3.19 mm at the distal end and 4.02 at the proximal end.It was noted the patient's vessel tortuosity was normal.The access vessel was the right femoral artery with normal vessel diameter.Dapt (dual antiplatelet treatment) was administered.The angiographic result post procedure was excellent.  ancillary devices include a penumbra neuron max 6f 088 guide catheter and a stryker synchro2 soft, 0.014in x 200cm guidewire.

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 after the device was back flushed, the plastic sheath was advanced into the hub of the micr ocatheter, and the pushwire was advanced.Resistance was immediately felt, pushing was stopped and the pushwire was pulled back to retrieve the device.

• 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: 15692615
• MDR Text Key: 307166465
• Report Number: 2029214-2022-01833
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284336
• UDI-Public: 00763000284336
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-400-14
• Device Catalogue Number: PED2-400-14
• Device Lot Number: B389397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2022
• Date Device Manufactured: 05/23/2022
• 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: 61 YR
• Patient Sex: Female