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

Model Number PED-350-20

Device Problems Break (1069); Activation Failure (3270)

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

Event Date 05/25/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for evaluation; therefore, the event cause could not be determined.Correspondence has been sent out for the device.Once the device has been received and investigation completed, a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report the physician released medtronic flow diverter, released the stent after riveting at the distal end, and found that the tip of the flow diverter was dropped, so the physician was ready to resheath and then released.At this time, it was found that re-sheathing was difficult.After repositioning, it was found that the flow diverter could not be released smoothly.After the overall withdrawal, the mark point of the end of the medtronic flow diverter was broken and the stent was unloaded.The flow diverter was removed.Although the pushwire was broken, it was still in the microcatheter and withdrawn as a whole.The broken part was removed out of the body with the catheter.Withdrew as a whole and replace a new stent to complete the operation.The patient underwent embolization treatment for a medium unruptured saccular aneurysm located in the left internal carotid artery in ophthalmic artery segment.Measuring 16.12mmx3.99mm, landing zone distal 3.7mm proximal 3.5mm.There were not any patient symptoms or complications associated with this event.No images available for review.

Manufacturer Narrative

D10: device available for evaluation - additional information.G4.Date mfr rec ¿ additional information.H2: type of follow up - device evaluation.H3: device evaluated by manufacturer- additional information.H6: codes updated the device was returned for evaluation and the clinical observation could not be confirmed.As received, only pipeline flex braid returned without pipeline flex pushwire.The distal and proximal ends of the pipeline flex braid appeared fully opened and moderately frayed.No other anomalies were observed.Without retuned the pipeline pushwire, any contribution of the pushwire to the issues could not be determined.The pipeline flex braid appeared fully opened and moderately frayed.The damage on the ends of the braid is likely the results of the physician re-sheathing the device more than recommended two times.Per our instructions for use (ifu): "begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex has successfully expanded, deploy the remainder of the device.Carefully inspect the deployed pipeline flex embolization device under fluoroscopy to confirm that it is completely apposed to the vessel wall and not kinked.If the device is not fully apposed or is kinked, consider using a balloon catheter, micro catheter, or guide-wire to fully open it.The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex embolization device.Re-sheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid.Discontinue delivery of the device if high force or excessive friction is encountered.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¿.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 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: 8704427
• MDR Text Key: 148187206
• Report Number: 2029214-2019-00571
• 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
• Report Date: 08/15/2019

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: 11/03/2021
• Device Model Number: PED-350-20
• Device Lot Number: A734811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Initial Date Manufacturer Received: 05/25/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 08/12/2019
• Supplement Dates FDA Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR