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

Model Number PED2-425-20

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that after the phenom 27 was placed in the m1, the ped2 was delivered and the sleeve was removed, and the ped2 was deployed from phenom 27, but when the ped2 was attempted to be retracted into the phenom 27 resistance was encountered.The tip of the ped2 could not be retracted, but it was moved together with the system and delivered to the ped2 deployment position to start deployment.At that time, the ped2 could not be retracted into the phenom 27 (pulling the system), but the ped2 was safely deployed only by pulling the phenom 27 and pushing the system.After deployment of the ped2, the phenom 27 could not be delivered to the tip to cover the sleeve.When the product was retrieved after the procedure, the connection part (pad fixing part) between the core wire part and the proximal bumper part was broken.It was considered that the pad fixing part was applied with a strong force during the procedure, so breakage occurred.In this procedure, the vessel route was good, so it was possible to deploy the product only by pulling the phenom 27 and pushing the system.No patient injury occurred.The devices were prepared and use per the instructions for use (ifu).The patient was treated for an unruptured, saccular, left internal carotid aneurysm.The max diameter was 18 mm and the neck was 7 mm.The distal landing zone was 3.3 mm and the proximal was 4.5 mm.The vessel anatomy was minimal in tortuosity.

Manufacturer Narrative

H3: the broken end was sent out for sem/eds testing.The sem results confirmed the damage: ¿fatigue features (stratiations) were observed, indicating the crack initiated via fatigue.The final crack area failed via tensile overload.¿ 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

D-4: expiration date.H-2.4: manufacture date 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.Product analysis: equipment used: video inspection system (m-77148), ruler (m-83360), camera (panasonic lumix dmc-zs5) pin gauge sets (m-84080 m-84082), in-house 0.026¿ mandrel the pipeline flex w/ shield (pli-10) (model: ped2-425-20 lot: a836552) was returned for analysis within a shipping box; within a resealable plastic biohazard pouch and within individual secondary resealable plastic biohazard pouch.The braid was implanted into the patient and not returned for analysis.The device was decontaminated per protocol.Proximal core wire found partially separated from hypotube with the ptfe jacket broken at the same area.No other damages found with pipeline flex w/ shield pusher.When compared to the drawing: the distal and proximal dps restraints were found to be intact.The hypotube appeared to be intact and with no stretching and the ptfe shrink tubing was found still intact.The dps sleeves were found intact with no signs of damage.No damages were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.The microcatheter was found kinked and flattened throughout the catheter between 26.6cm from the proximal end to 1.0cm from the distal end.The marker band was found intact, but the catheter tip was found slightly crushed.Micro catheter was flushed, and water exited the distal end.A 0.0260¿ mandrel was used for resistance testing and became stuck at 26.4cm when inserted into the hub and at 1.3cm when inserted into the distal tip.No other anomalies were observed.The customer¿s report of resistance was confirmed as resistance was encountered within the catheter with in-house mandrel.The damages found on the catheter likely caused the resistance.Possible causes for catheter damage are patient vessel tortuosity, flush rate too low or lack of continuous flush, guidewire or delivery system damage, material occludes catheter or insufficient guidewire or delivery system hydration.Customer reported vessel tortuosity as minimal and devices were prepared and used per instruction per use.The customer report of pushwire break/separation was confirmed.It is likely the cause of the d amage found to the pusher and micro catheter occurred during the reported ¿strong force¿ used during the procedure against the reported resistance.Per instructions for use (ifu): "discontinue delivery of the device if high force or excessive friction is encounter ed.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Review of proximal delivery system subassembly documentation (p/n 50648-001 lot 795519) found no discrepancies for dimension iqc14: proximal and distal weld inspection.Certificate of conformance shows tensile strength of wire to hypotube strength between 66.2n to 74.4n, which is within specification.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 W/SHIELD TECHNOLOGY
• Type of Device: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10184498
• MDR Text Key: 196920564
• Report Number: 2029214-2020-00582
• Device Sequence Number: 1
• Product Code: OUT
• 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: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2022
• Device Model Number: PED2-425-20
• Device Catalogue Number: PED2-425-20
• Device Lot Number: A836552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Date Manufacturer Received: 08/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1