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

Model Number PED-325-16

Device Problem Break (1069)

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

Event Date 12/22/2020

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 delivery wire fractured just proximal to the resheathing pad.The patient was undergoing treatment for an unruptured, amorphous aneurysm located in the distal ica.The max diameter was 10 mm.The patient¿s vessel tortuosity was minimal.Dual antiplatelet treatment had been administered.The landing zone was 3 mm distal and 3 mm proximal.It was reported that the phenom 27 was advanced through the pipeline after successful deployment of the pipeline device and upon retrieval of the delivery wire.While attempting to capture the delivery system and ptfe sleeves, the delivery wire fractured just proximal to the resheathing pad.The doctor felt this happen, removed the phenom 027, and was able to retrieve the delivery wire and fractured distal segment as it got lodged in the phenom 027.All parts were successfully removed, and the pipeline was successfully deployed.The patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a benchmark sheath, sofia guide catheter, and phenom 27 microcatheter.

Event Description

No additional information received.

Manufacturer Narrative

H3: analysis of the pipeline flex pusher (model: ped-325-16, lot: a898546) found that no damages or irregularities with the proximal pusher.The hypotube was found intact and unstretched.The outer jacket was found undamaged.The distal wire was found separated from the hypotube proximal to the wire weld.Dried blood was found within the hypotube bumper hole.The distal pad restraint and the re-sheathing pad were found still secure on the distal wire and undamaged.The tip coil was found intact and unstretched.No other damages or irregularities were found with the distal wire, dps sleeves or sleeve restraints.No other anomalies were observed.The separated wire was sent out for scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) testing.Based on the analysis findings, the customer report of ¿pushwire break/separation¿ was confirmed.The distal wire of the pipeline flex delivery system was possibly detached due to the solder tensile failure when attempting to retract the pipeline flex against resistance.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.As the phenom-27 catheter used in the event was not returned for analysis, any contribution of the phenom-27 catheter towards the separation could not be determined.H6: method code updated to b19.Result code updated to c070603.Conclusion code updated to d15.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
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11119364
• MDR Text Key: 225564113
• Report Number: 2029214-2021-00013
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015067
• UDI-Public: 00847536015067
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2022
• Device Model Number: PED-325-16
• Device Catalogue Number: PED-325-16
• Device Lot Number: A898546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1