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

Model Number PED2-450-16

Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 11/26/2020

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 in the distal end.The device was unsheathed to the point of no return, resheathed, and unsheathed again, but it still didn't open.The pipeline also got stuck in the hub of the microcatheter when attempting to remove.More than 50% of the device was deployed when failed to open, with less than or equal to 2 resheathing attempts made.There were no additional steps taken.The system was removed from patient and replaced with a competitor device.The patient's vessel tortuosity was normal.

Manufacturer Narrative

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.

Event Description

Additional information received indicated that the patient's vessel tortuosity was normal.The devices were prepared as indicated per the ifu, and the device was placed in a straight segment.

Manufacturer Narrative

H3: the pipeline flex with shield embolization device (model: ped2-450-16, lot: a788708) and phenom catheter (model: fg15150-0615-1s, lot: jl19-068) were returned for analysis.The pipeline flex with shield was returned outside the phenom catheter.The dps sleeves were found intact with no signs of damage.The distal hypotube was found to be stretched.No bent or kink were found with the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The pipeline flex with shield braid appeared to be stuck in catheter hub.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub to remove the braid.The mandrel successfully passed through the catheter hub and tip and the braid pushed out from the catheter with no issues.The proximal end of the pipeline flex with shield braid was found fully open and moderately frayed.However, the distal end of the pipeline flex with shield braid was not open and moderately frayed.The total and usable lengths of the catheter were measured to be within specifications.The catheter tip, body and marker were examined; no damages were found.No flash or voids molded were observed in the hub.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿failure to open at distal¿ and ¿catheter resistance at hub¿ were confirmed.The braid was stuck inside the catheter hub.The distal end of the pipeline flex with shield braid was not open and damaged.However, the cause for damage could not be determined.The pipeline flex with shield pushwire was damaged.From the damages seen on the hypotube (stretching), pipeline flex with shield braid (fraying); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance the pipeline flex with shield pushwire through the phenom catheter against resistance.Based on the returned devices, there was no non-conformance to specifications identified that led to the resistance.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: 10928857
• MDR Text Key: 219523246
• Report Number: 2029214-2020-01213
• 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,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2022
• Device Model Number: PED2-450-16
• Device Catalogue Number: PED2-450-16
• Device Lot Number: A788708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1