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

Model Number PED2-500-16

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2020

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 proximal section of the pipeline failed to open.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the para-ophthalmic artery.The max diameter was 4 mm, and the neck diameter was 4 mm.The landing zone was 4 mm distal and 5.2 mm proximal.The patient¿s vessel tortuosity was normal.It was reported that the proximal part of the pipeline would not open despite manipulation.The device had not been positioned in a bend, and over 50% failed to open.More than 2 re-sheathing attempts were made, and the device was replaced.No steps other than were re-sheathing were attempted.The patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a phenom microcatheter.

Manufacturer Narrative

Product analysis findings: the pipeline flex w/ shield (model: ped2-500-16 lot: b043136) and phenom-27 micro catheter were returned for analysis the pipeline flex w/ shield was advanced out of the phenom-27 micro catheter against resistance.No damages or irregularities were found with the proximal pusher.The hypotube was found intact and unstretched.The distal wire was found separated from the hypotube proximal to the wire weld.The distal pad restraint and the re-sheathing pad were found loose on the distal wire.The tip coil was found intact and unstretched.No other damages or irregularities were found with the distal wire, dps sleeves or sleeve restraints.Once pushed out from within the catheter, the proximal braid was found fully opened and frayed and the distal braid was found tapered, damaged and frayed.No other anomalies were observed.Based on the analysis findings, the customer report of ¿failure/incomplete open proximal (flex)¿ was confirmed as the distal braid was still tapered during analysis.Possible causes for failure are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid overstretched during delivery, braid deployed within vessel bend, presence of other indwelling endovascular stent or inappropriate anatomy.Customer reported, vessel tortuosity as normal, device not positioned in a bend, device prepared as per ifu and more than 2 resheathing attempts were made.The distal wire of the pipeline flex w/ shield delivery system was possibly detached due to the solder tensile failure when attempting to retract the pipeline flex w/ shield against resistance.A review of the manufacturing process did not uncover any deficiencies with regard to the soldering process.Proper soldering technique and surface preparation (tinning) were well defined and documented appropriately in the associated manufacturing procedures.In addition, the elemental analysis conducted through scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) showed presence of soldering material (tin); thereby indicating that the soldering was conducted.The proof load of 2.5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).There was no non-conformance to specification that lead to the detachment 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: 10936780
• MDR Text Key: 219336813
• Report Number: 2029214-2020-01224
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2023
• Device Model Number: PED2-500-16
• Device Catalogue Number: PED2-500-16
• Device Lot Number: B043136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Date Manufacturer Received: 02/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 72