MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; LASER THERAPY PRODUCT

Model Number PED-450-20

Device Problems Material Deformation (2976); Activation Failure (3270)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2020

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 pipeline failed to open, and the marksman was kinked.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right ophthalmic artery with a max diameter of 3.42mm and a 2.30mm neck diameter.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered and the pru level was 40.It was reported that the tip of the pipeline was deployed, anchored, and then deployed.The stent was kinked when passing through a curved blood vessel, and it couldn't be deployed after repeated pushing and pulling.After two attempts, the stent still couldn't be opened, and the stent had a certain displacement.As a result, the whole system was withdrawn from the patient.After withdrawn, it was found that the distal soft section of the marksman microcatheter was kinked, and the pipeline tip had burrs.A new phenom microcatheter and stent were then used to successfully complete the surgery.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiographic results showed normal results and the aneurysm had blood retention.Ancillary devices include a 7f cook long sheath and synchro 14 guidewire.

Event Description

Additional information received from the physician indicated that the pipeline failed to open in the middle section.The pipeline was placed in a vessel bend when it failed to open.The surgeon attempted to push and pull the stent during preparation, and tried to retrieve/release the sent as an additional attempt to deliver.

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 marksman catheter (model: fa-55150-1030, lot: 218379403) (pli-10) and pipeline flex embolization device (model: ped-450-20, lot: b013804) (pli-20) were returned for analysis.(pli-10) upon visual inspection, no damages were found with the marksman hub or distal tip; however, the pipeline flex pushwire was found extending ~45.2cm from the marksman catheter hub.No bends or kinks were found with the marksman catheter body.The marksman total length was measured to be ~158.5cm (reference: 157.0cm).The marksman useable length was measured to be ~151.0cm which is within specification (specification: 150.0cm ± 3cm).The marksman catheter was flushed, and water exited the distal tip.The pipeline flex delivery system was then pushed out from the marksman catheter without issue.No other anomalies were observed.(pli-20) no bends or kinks were found with the pipeline flex pushwire.The distal hypotube was found to be intact with ptfe shrink tubing pulled back.The pusher was found detached at the distal hypotube weld (solder joint).The proximal bumper and re-sheathing marker were found to be missing.The re-sheathing pad was found to be stuck within proximal end of braid.The dps restraints/sleeves appeared to be in good condition.The tip coil was found intact.The proximal end of braid was found to be collapsed and the distal end of braid was found to be opened and frayed.The detached pushwire was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.The elemental analysis of the detached pushwire end shows tin (sn) was detected on the wire surface, and it is not possible to determine the failure mechanism of the subject wire.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿catheter kink/damage¿ was unable to be confirmed as no damages were found with the marksman catheter.Based on the device analysis and reported information, the customer¿s report of ¿pipeline damaged during delivery/retrieval¿ was confirmed as the pipeline flex device was found to be separated at distal hypotube.However, the root cause could not be determined.Possible causes for ¿pipeline damaged during delivery/retrieval¿ include re-sheathing more than 2 times, high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, deploying/re-sheathing braid against resistance and use of incompatible device.The investigation determined that these events were similar to events that had already been investigated, and another investigation is not necessary.Regarding the solder joint separation issue, in addition to excessive force, separation can occur due to inadequate solder/tinning.As the analysis showed presence of soldering material (tin); thereby indicating that the soldering was conducted.A review of the manufacturing process did not uncover any deficiencies with regard to the soldering process.Proper soldering technique and surface preparation (tinning) were well defined and documented appropriately in the associated manufacturing procedures.The proof load of 2.5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).There was no non-conformance to specification that lead to the resistance and detachment issues.Furthermore, the review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open distal¿ was confirmed as the pipeline flex braid was found to be collapsed and frayed.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.

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.

• Brand Name: PIPELINE FLEX
• Type of Device: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10505082
• MDR Text Key: 207756702
• Report Number: 2029214-2020-00906
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016477
• UDI-Public: 00847536016477
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2023
• Device Model Number: PED-450-20
• Device Catalogue Number: PED-450-20
• Device Lot Number: B013804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR