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

Model Number PED2-375-20

Device Problem Migration (4003)

Patient Problems Neurological Deficit/Dysfunction (1982); Paresis (1998)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned as it was implanted in the patient.Neurological deterioration is known inherent risk of endovascular procedure and is documented in our device¿s instruction for use (ifu).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that post the pipeline flex with shield embolization, the patient developed right side hemiplegia and aphasia.No bleeding, no diffusion hi were noted.During implantation for stent, the sleeve of the pipeline did not come off.When an attempt was made to continue performing the implantation, the proximal region fell into the aneurysm.When trying to deliver the marksman distally via delivery system, it came off together with the delivery system.An attempt was made to perform the approach on the ipsilateral side, but guidewire did not pass through.Via a-com, the product was pulled up from the contralateral side through guidewire, and the true path was delivered with a gooseneck snare.Marksman was inserted again, and the second pipeline (ped-2-400-20) was implanted additionally.The patient was treated for left internal carotid artery unruptured aneurysm.The aneurysm was saccular, 20 mm max diameter and 5mm neck.The distal landing zone was 3.3mm and the proximal was 3.5mm.The anatomy was normal in tortuosity.The devices were all prepared and used per the instructions for use (ifu).

Manufacturer Narrative

The pipeline flex with shield pusher was returned inside of a biohazard bag and a shipping box.There was no pipeline flex shield braid or catheter returned with the pusher.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.No bend was found on the pusher.No damages were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.No other anomalies were observed.Based on the returned pusher, the pipeline flex shield was not confirmed to have device migration.The root cause could not be determined as the pipeline flex shield braid was not returned.In addition, no images were provided for review.No damage was found with the pipeline flex pusher.Since the pipeline flex shield braid was not returned; any contribution of the braid to the issue could not be determined.There was no non-conformance to specifications identified that led to the reported issue.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Per our instructions for use (ifu): ¿select an appropriately sized pipeline flex shield embolization device such that its fully expanded diameter is equivalent to that of the largest target vessel.An incorrectly sized pipeline flex shield embolization device may result in inadequate device placement, incomplete opening, or migration.¿ 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: the patient's current situation is that there is slight paralysis remained in the right hand, but there are no other problems.

• Brand Name: PIPELINE FLEX WITH SHIELD
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8812981
• MDR Text Key: 151775243
• Report Number: 2029214-2019-00769
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-375-20
• Device Lot Number: A787916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 58