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

Model Number PED-250-18

Device Problems Positioning Failure (1158); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 03/01/2023

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.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 pipeline protective sheath could not be recovered.Was damaged.And implanted at an unintended point.The guide catheter was also damaged.The patient was undergoing surgery for treatment of a saccular, unruptured multiple aneurysms on the left side in the m1 segment of the middle cerebral artery with a max diameter of 3mm and a 2.5mm neck diameter.The landing zone was 2.41mm at the distal end and 2.39mm at the proximal end.It was noted the patient's vessel tortuosity was minimal.The access vessel was the femoral artery with 6mm diameter.The angiographic result post procedure was obvious stagnation, stent adhered well.It was reported that after being deployed according to the normal process.When the protective sleeve at the tip end of the stent was ready to be recovered.The protective sleeve could not be recovered and the stent was involved.In the end.After various adjustments.It was never properly retracted.Resulting in damage to the stent and failing to cover the aneurysm as intended at the anchor point.Additionally.After the guide catheter entered the patient's blood vessel according to the normal process.The catheter could not be pushed to go upper.And the blood vessel had obvious spasm.After the catheter was withdrawn, it was found that the tube body was dented and kinked.The damage was located on the distal segment.The pipeline was used for an indication that is approved (on-label).The reported devices and any accessory devices were prepared as indicated in the ifu.Ancillary devices include a rfx072-115-08mp guide catheter.

Event Description

Additional information was received that the patient was in good condition after the operation.The vasospasm was relieved by adjusting the position of the catheter, intraoperative angiography, etc., and the operation date was (b)(6) 2023.After evaluating the parent artery and its branch vessels, a dense mesh stent was chosen to bridge again to cover the aneurysm.The operation date was (b)(6) 2023.The procedure was completed with another stent and was bridged and the operation was successfully completed.The specific cause of the vessel spasm was unable to be determined.

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

H3: the pipeline flex embolization device and navien catheter were returned for analysis within dispenser coils.No bends or kinks were found with the pipeline flex pusher.The pusher resheathing pad and sleeves were found in good condition.The tip coil distal core wire was found broken.The broken tip coil and braid were not returned.No damages were found with the navien catheter hub.No bends or kinks were found with the navien catheter body.The navien catheter distal tip was noted to be preshaped.The navien catheter distal tip was found in good condition.The broken pipeline flex distal core wire was sent out for sem (scanning electron micrographic) failure analysis.Per the analysis report, the wire failed via tensile overload.Based on the device analysis and reported information, the customer¿s ¿difficult placement/positioning¿ report could not be confirmed.In this event, it is likely the difficulty during resheathing contributed to the difficult placement/positioning of the pipeline flex braid.However, the cause for the difficult placement could not be determined.Regarding the customer¿s ¿pipeline damage¿ report, the issue was confirmed as the tip coil was found broken.Damage can occur due to resheathing more than 2 times, over-manipulation, or delivering/retracting delivery wire against resistance.As the distal core wire failed via tensile overload it is likely there was over-manipulation and the delivery system was retrieved against resistance.Regarding the customer¿s ¿catheter kink/damage¿ re port the issue could not be confirmed.No defect was found with the returned navien catheter.Regarding the customer¿s ¿difficult navigation¿ report the issue could not be confirmed.In this event, it is likely the reported vessel spasm contributed to the difficulty during navigation.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: 16477703
• MDR Text Key: 310705744
• Report Number: 2029214-2023-00392
• 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
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-250-18
• Device Catalogue Number: PED-250-18
• Device Lot Number: B324605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 03/09/2023; 05/02/2023
• Supplement Dates FDA Received: 03/15/2023; 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2022
• 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 Outcome(s): Required Intervention; Other