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

Model Number PED-500-16

Device Problems Unintended Movement (3026); Activation Failure (3270)

Patient Problem Embolus (1830)

Event Date 04/20/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a pipeline that would not open at the distal end.The patient was being treated for a ruptured triangular aneurysm with fusiform qualities of the right internal carotid artery that contributed to subarachnoid hemorrhage.The aneurysm had a neck diameter of 3mm.The landing zone was 3.5mm at the distal end and 5mm at the proximal end.Vessel toruosity was moderate.It was reported that the device was prepared according to the manufacturer instructions for use.The device was delivered through the microcatheter.Difficulty with delivery was experienced at the carotid terminus and the catheter, which was in the distal m1, came back to a1.The catheter was able to be guided distal and the pipeline was deployed into the proximal m1 segment but the distal end did not open well.The device was resheathed and retried several times but never opened well.The pipeline was removed through the catheter and upon removal, it appeared deformed at in the distal segment.The surgical scrub tech massaged the device at the surgical table and was able to get it to open somewhat.Another pipeline was used to complete the procedure.The patient developed a clot in the m2 due to the prolonged procedure.The clot was treated and resolved with medication.Ancillary devices: phenom-27 microcatheter, navien 058 guide catheter.

Manufacturer Narrative

Codes updated as received, pipeline flex braid was returned for analysis without the pipeline flex pushwire.The braid was found fully opened, however, the braid was damaged throughout the length of the braid and the two ends were found damaged and frayed.No other anomalies were observed.The customer report of ¿failure/incomplete open distal (flex)¿ could not be confirmed as the device was returned fully opened on both sides.Customer reported that the braid shape was manipulated post procedure.The braid was found damaged and frayed.It is possible that the damage occurred when attempting to advance the device against the reported resistance, during one of the repeated repositioning, or damage during return shipment to medtronic for analysis as the device was returned without its protective dispenser coil and introducer sheath.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.

Event Description

Additional information received indicated that the second pipeline and the phenom catheter had been discarded.There was not another episode of embolism, and post-procedure, the patient was given integrilin.As of 2020-05-15, the physician reported the patient was doing well and home.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9988318
• MDR Text Key: 189913346
• Report Number: 2029214-2020-00385
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536019669
• UDI-Public: 00847536019669
• 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: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2021
• Device Model Number: PED-500-16
• Device Catalogue Number: PED-500-16
• Device Lot Number: A612630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2020
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention