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

Model Number PED2-500-14

Device Problem Activation Failure (3270)

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

Event Date 06/25/2020

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 segment of the pipeline embolization device failed to open.It was reported that more than 50% had been deployed when it failed to open, and it was not placed in a bend.The physician recaptured it twice but the distal part would not open.Another stent (leo stent) was tried, which also was not successfully placed.The physician decided to treat the aneurysm with a balloon and coils.The patient did not experience any injury or complications.The angiographic results were said to be ¿okay¿ post procedure.The devices were prepared according to the instructions for use (ifu).Dual antiplatelet treatment was administered and the pru levels were normal.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the ophthalmic internal carotid artery.The max diameter was 6.5 mm.The vessel tortuosity was severe.Ancillary devices include a phenom 27 microcatheter.Additional information: leo 4.5x20 stent, lot00372888 from balt used.The deployment was not satisfied, therefore, device was not implanted.Leo has been discarded and ped has been returned.

Manufacturer Narrative

H3: the pipeline flex w/ shield distal wire and braid were found stuck within the phenom-027 micro catheter hub and proximal section.No damages or irregularities were found with the exposed pipeline flex w/ shield pusher.The phenom-027 total length was measured to be 156.6, the usable length was measured to be 150.6cm and the distal single coil length was measured to be 14.6cm, which is within specification.No damages or irregularities were found with the phenom-027 hub, catheter body or distal tip.The phenom-027 was flushed and water did not exit the distal end.A mandrel was inserted distally to try to push out the braid, however, the braid would not move.The hypotube was found intact and unstretched with the ptfe jacket intact.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No damages were found with the distal marker, re-sheathing marker or with the proximal bumper.The tip coil tip was found damaged.The phenom-027 micro catheter distal inner diameter was measured to be 0.027¿ which is within specification and compatible for use with the pipeline flex w/ shield.The proximal end could not be measured as it was destroyed during the removal of the pipeline flex w/ shield.Both ends of the braid were found tapered, damaged, and frayed.The middle braid section was also found damaged.No other anomalies were observed.Based on the analysis findings, the customer report of ¿failure/incomplete open distal (flex)¿ was confirmed as the braid was returned with both ends tapered.Possible causes for failure are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid overstretched during deliver, user deploys braid in vessel bend, presence of other indwelling endovascular stent and inappropriate anatomy.Customer reported that the vasculature was severe in tortuosity, device was prepared as indicated per ifu, and the device was not position in a bend.The pipeline flex w/ shield coil tip and braid were found damaged.It is likely that the damages found on the coil tip and braid occurred during the removal of the device from the phenom-027 micro catheter hub.The cause of the resistance within the micro catheter could not be determined.Potential causes for catheter resistance are flush rate too low, catheter or pipeline damage, material occludes catheter, insufficient catheter flushing or lack of continuous flush or insufficient delivery system hydration.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: 10274517
• MDR Text Key: 202229501
• Report Number: 2029214-2020-00691
• 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: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2021
• Device Model Number: PED2-500-14
• Device Catalogue Number: PED2-500-14
• Device Lot Number: A659366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Date Manufacturer Received: 08/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR