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

Model Number PED-450-16

Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 07/06/2020

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 the pipeline deployed well at the distal landing zone but was unable to open in the anterior genu.Multiple attempts were made to fully open the device.Upon further angiographic visualization it looked as though the device may have been twisted.The physician decided to pull out the device and use another size.During retrieval of the pipeline, the pipeline become stuck in the hub portion of the catheter.This device did not leave the catheter.Another catheter was utilized to deliver another pipeline.The devices were prepared and used per the instructions for use (ifu).The catheter was flushed as per the ifu.Ancillary device: phenom 027.Post procedure the angiographic results did not change.The treatment location was in the right internal carotid artery (ica).The aneurysm was saccular and unruptured.The distal landing zone was 3.5 mm and the proximal was 4.4 mm.The vessel anatomy was minimal in tortuosity.No patient injury occurred.

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 received reported the pushwire did not separate or break.Resistance was not felt when the pipeline was advanced or retrieved.

Manufacturer Narrative

H3: a pipeline flex embolization device (model: ped-450-16 lot: a908295) (pli-10) and phenom catheter (model: fg15150-0615-1s lot: nv19-021) (pli-20) was returned for analysis.(pli-20) no damages were found with the phenom hub; however, the pipeline flex braid was found stuck within the phenom catheter hub.No bends or kinks were found with the phenom catheter body.No damages were found with the phenom distal tip.The pipeline flex braid was then removed from the phenom catheter.The pipeline flex delivery system portion (pushwire, proximal pad restraint, re-sheathing pad, re-sheathing marker, dps sleeves, braid and tip coil) was found to be missing and not returned.No damages or irregularities were found with the phenom-27 hub.No flash or voids molded were observed in the hub.No damages or irregularities were found with the tip and marker band.The catheter total length was measured and found to be ~158.6cm and the usable length was found to be ~152.0cm which is within specification.An in-house 0.026¿ mandrel was inserted through th e phenom catheter hub and exited without issue.(pli-10) the pipeline flex embolization subassembly was not returned.Proximal end of braid was found to be collapsed and distal end of braid was found to be opened and frayed.No other damages or anomalies were found with the device.Based on the analysis findings, the customer¿s report of ¿stuck in catheter hub¿ and ¿catheter resistance at hub¿ were confirmed as the braid was found to be stuck within phenom hub.There was no device malfunction or non-conformance to specifications identified that led to the resistance during delivery.Based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open distal¿ was confirmed as the pipeline flex braid proximal braid was found to be collapsed.Possible causes could be vessel tortuosity or re-sheathing the device more than the recommended two times.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.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: 10251150
• MDR Text Key: 198368578
• Report Number: 2029214-2020-00678
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016415
• UDI-Public: 00847536016415
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: PED-450-16
• Device Catalogue Number: PED-450-16
• Device Lot Number: A908295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR