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

Model Number PED-400-30

Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

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

Event Date 09/09/2019

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 resistance was felt, causing the pipeline to become stuck at the microcatheter hub.Upon retrieving the device it was noticed that the pipeline was severely bent and fell off at the proximal end of the microcatheter after withdrawal.The patient was undergoing surgery for treatment of an unruptured, amorphous aneurysm with a max diameter of 6mm and a neck diameter of 6mm.Dual antiplatelet treatment was administered, the pru level was not measured.Post angiographic results showed partial residue.It was noted that the patient's vessel tortuosity was moderate.The devices were prepared as indicated per the ifu.There was no catheter or pushwire damage, the catheter was continued to be used.There were no related patient symptoms.

Manufacturer Narrative

D10: device available for evaluation - additional information.G4.Date mfr rec ¿ additional information.H2: type of follow up - correction.H3: device evaluated by manufacturer- additional information.H6: codes updated based on the initial report this pipeline flex device had only resistance issue.The pipeline flex device did not have detachment is sue.Device returned for analysis and found the dps sleeves were found intact and fully opened with no signs of damage.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pipeline flex braid were opened and moderately frayed at both ends.Bends found on the pushwire at the proximal end.There was not any device detach or separation found.Based on the further review of the event and device evaluation, this would not meet the criteria for a reportable event.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.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 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: 9011354
• MDR Text Key: 168451831
• Report Number: 2029214-2019-00917
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015999
• UDI-Public: 00847536015999
• 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
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2022
• Device Model Number: PED-400-30
• Device Catalogue Number: PED-400-30
• Device Lot Number: A797722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR