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

Model Number PED2-475-20

Device Problem Activation Failure (3270)

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

Event Date 09/16/2020

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 pipeline failed to open.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right internal carotid artery c5-c6 segment with a max diameter of 10.8 mm and a 8.3 mm neck diameter.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered via plavix (6 tablets before 3 days) and continued 1x1 until the procedure.It was reported that the physician started to unsheath the pipeline device, but the distal part of the device didn't open.After 50% of the device was opened, a twist occurred.Resheathing and redeploying was done four times, but the twist and distal failure to open did not resolve.The pipeline was not positioned in a bend, and no additional steps were performed to open the device.The stent was removed from the patient, and a replacement device was 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.Ancillary devices include a phenom 27 microcatheter, lot #: my19-13.

Event Description

No additional information received.

Manufacturer Narrative

H3: analysis of the pipeline flex w/ shield (model: ped2-475-20, lot: b015352) and phenom-027 micro catheter (model: fg15150-0615-1s, lot: my19-031) found: the phenom-027 micro catheter total length was measured to be ~154.9cm, the usable length was measured to be ~148.3cm and the distal single coil length was measured to be ~14.3cm, which is within specification: total (reference) = 156.5cm, usable = 150cm ± 5cm, distal single coil = 15cm ± 2cm.No flash or voids molded were found within the catheter hub.No damages or anomalies were found with the hub, catheter lumen, distal tip or marker bands.The micro catheter was flushed, and water did not exit out from the catheter tip.The pipeline flex w/ shield device was found stuck within the phenom-27 and cannot be advanced or retracted out.The phenom-27 catheter was destroyed to remove the pipeline.Dried blood was found throughout the phenom-27 catheter and on the pipeline pusher and braid.No damages were found with the proximal pusher.The hypotube was found stretched.When compared to the drawing: the distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The ptfe shrink tubing was still intact.No damages were found with the distal marker, re-sheathing marker or with the proximal bumper.The tip coil was found damaged.Once deployed out of the micro catheter the distal braid did not open.After the blood was dissolved, the distal and proximal ends of the pipeline flex shield braid were found fully opened.The distal braid end was found damaged and frayed.No other anomalies were observed.Based on the analysis findings, the customer report of ¿failure/incomplete open distal (flex)¿ was confirmed as the distal braid was found tapered.Possible causes for failure are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid o verstretched during deliver, user deploys braid in vessel bend, presence of other indwelling endovascular stent and inappropriate anatomy.The coagulated blood contributed towards the incomplete open during device analysis.The hypotube was found stretched and the tip coil was found damaged.Possible causes for damage are patient vessel tortuosity, user advances/retracts device against resistance or continuous flush was not administered during the procedure.As blood was found throughout the phenom-27, it is possible that insufficient continuous flush was used, causing the blood to flow back up the micro catheter.No issues were found with the phenom-27 catheter.H6: conclusion code updated to d15.Result code updated to c0702 and c070601.Method code updated to b01.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: 10558184
• MDR Text Key: 207717077
• Report Number: 2029214-2020-00948
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2023
• Device Model Number: PED2-475-20
• Device Catalogue Number: PED2-475-20
• Device Lot Number: B015352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 68