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

Model Number PED2-475-12

Device Problem Activation Failure (3270)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2020

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 the distal end of the pipeline failed to open.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left para-ophthalmic internal carotid artery with a max diameter of 7mm and a 5mm neck diameter.It was noted the patient's vessel tortuosity was severe.It was unknown if dual antiplatelet therapy (dapt) had been administered.It was reported that the doctor placed the phenom 27 microcatheter distal to the aneurysm, but they were unable to open the distal end of the pipeline properly despite several attempts.The proximal and distal parts of the device were positioned in a bend, more than 50% of the device had been deployed when it failed to open, and resheathing was performed more than twice.The physician tried manipulating the devices to take the forward tension off the system, and there was some distal opening, but it was never complete.Eventually, the phenom and pipeline were removed together.The doctor pushed the pipeline partially out of the distal end of the phenom to inspect, and it looked compressed.A replacement device was then used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiographic imaging showed very good results.

Manufacturer Narrative

H3: the pipeline flex embolization device (model: ped2-475-12, lot: a757781) and phenom-27 catheter (model: fg15150-0615-1s, lot: ja20-019) were returned for analysis.The pipeline flex embolization device braid was removed from within the phenom catheter.The pad and marker were found to be stuck to proximal end of braid.No bends or kinks were found with the pipeline flex pushwire.The distal hypotube was found to be intact with the ptfe shrink tubing pulled back.The distal corewire was found to be broken at ~4.3cm from proximal bumper.The proximal bumper was found to be intact.The in-house mandrel was then reinserted through the phenom catheter and the proximal restraint, dps sleeves and tip coil were pushed out of tip.The dps sleeves appeared to be in good condition.The tip coil was found to be intact.The pipeline flex braid proximal end was found to be collapsed and frayed.The distal end of braid was found to be opened and frayed.The broken corewire was sent out for sem (scanning electron micrographic).Per the sem report, the wire end exhibits significant corrosion.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open distal¿ was confirmed as the pipeline flex braid was found to be collapsed and frayed.However, the root cause could not be determined.The investigation determined that these events were similar to events that had already been investigated, and another investigation is not necessary.There was no non-conformance to specification that lead to the failure/incomplete open distal and corewire break issues.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 W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10488482
• MDR Text Key: 205662298
• Report Number: 2029214-2020-00886
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2021
• Device Model Number: PED2-475-12
• Device Catalogue Number: PED2-475-12
• Device Lot Number: A757781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR