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

Model Number PED2-500-12

Device Problems Material Deformation (2976); Activation Failure (3270)

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

Event Date 03/21/2022

Event Type  malfunction  

Event Description

Medtronic received a report that the pipeline shield devices was prepped in standard fashion according to the ifu.They used an 8fr ballast sheath, 058 navien, and phenom 27 mc.Md attempted to unsheath and resheath in m1 as part of deployment technique.During the process of landing the device (drag and drop) in the distal ica, it was noticed the end of the device was shaped like a trumpet and would not open.Tried various techniques/tricks such as loading/unloading the system, letting out more device, resheathing and redeploying, but nothing worked.Doc decided to bail on the device and try another pipeline device.When he pushed it out on the back table it was noticed how the distal end was frayed.The pipeline was not positioned in a bend, more than 50% was deployed when it failed to open.It was resheathed less than or equal to 2 times, and it was removed with the microcatheter.No patient symptoms or further complications were reported as a result of this event.  the patient was undergoing surgery for treatment of a amorphous, unruptured aneurysm in the left ica, sidewall pcom with a max diameter of 7mm and a 4mm neck diameter.The landing zone was 5mm on the distal and proximal ends.It was noted the patient's vessel tortuosity was moderate. dapt (dual antiplatelet treatment) was administered, pru level was 3.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3: a pipeline flex embolization device was returned for analysis within a shipping box; within an opened pipeline flex embolization device outer carton and within a sealed vial.Visual inspection/damage location details: the pipeline flex assembly was not returned; therefore, any contributing factors could not be assessed.Due to the condition in which the braid was returned the proximal and distal ends of braid were unable to be determined.Braid end 1 was found to be opened and frayed.Braid end 2 was found to be opened and appeared to be in good condition.No other anomalies were observed.Testing/analysis (including sem reports): n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open distal¿ was unable to be confirmed as both braid ends were found to be opened.Possible contributing factor to failure to open is vessel tortuosity.Based on the device analysis and reported information, the customer¿s report of ¿pipeline damaged during delivery/retrieval¿ was confirmed.However, the root cause could not be determined.Possible causes for ¿pipeline damaged during delivery/retrieval¿ include high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, deploying/re-sheathing braid against resistance and use of incompatible device.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
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14069104
• MDR Text Key: 295694567
• Report Number: 2029214-2022-00605
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284688
• UDI-Public: 00763000284688
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-500-12
• Device Catalogue Number: PED2-500-12
• Device Lot Number: B290142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female