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

Model Number PED2-350-12

Device Problems Break (1069); Physical Resistance/Sticking (4012)

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

Event Date 08/07/2023

Event Type  malfunction  

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

Medtronic received a report that the push wire broke at the tip coil as it went into the phenom27 to retrieve the first pipeline used in the procedure.The physician was able to remove the whole system without damage to the patient.There was moderate friction during retrieval.Another pipeline was used to complete the procedure.The pipeline was not used for an off-label use.The pipeline and any accessories were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.  the patient was undergoing surgery for treatment of a saccular, unruptured left internal carotid artery (ica) aneurysm with a max di ameter of 12mm and a 12mm neck diameter.It was noted the patient's vessel tortuosity was moderate.The post procedure angiographic result showed that the first pipeline was retracted with nothing left in the patient and the second pipeline was deployed successfully.  ancillary devices include a cerebase da sheath, axs catalyst 5 guide catheter, a phenom 27 microcatheter, and an aristotle 24 guide wire.

Manufacturer Narrative

Product analysis #705753214:¿ equipment used: video inspection system (m-78210), ruler (m-83361) ¿ as found condition: the pipeline flex shield embolization device, phenom 27 catheter and non-medtronic catheter were returned for analysis within a shipping box; within a plastic bio-pouch; and within an opened pipeline flex sheild outer carton and inner pouch.The pipeline flex pusher was returned within the phenom 27 catheter.¿ damage location details: the pushwire was returned extending out from the hub.The pushwire was found to be bent at ~33.0cm from proximal end.No break or separation was found with pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.No defects were found with the proximal bumper, re-sheathing pad, re-sheathing marker, distal marker, and tip coil.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The braid was returned already detached from the pusher; therefore, the proximal and distal ends could not be identified.The distal and proximal ends of pipeline flex sheild braid were found fully opened and frayed.No flash or voids molded were observed in the hub.No damage was found with hub.No bent or kink was found with phenom 27 catheter body.The phenom 27 catheter distal tip and marker band were examined; and no damages were found.No damages were found with non-medtronic catheter.No other anomalies were obser ved.¿ testing/analysis: the pushwire was pushed out from catheter lumen without any issues.The total and usable lengths of the catheter were measured to be within specifications.The catheter was flushed with water and water exited out from the distal tip.An in-house mandrel was inserted into the marksman micro catheter hub and catheter lumen without issue.¿ conclusion: based on the analysis findings, the pipeline flex sheild was confirmed to have resistance during retrieval.However, the pipeline flex shield could not be confirmed to have break or separation as no break was found with pushwire.The pipeline flex sheild pushwire was found to be damaged.From the damages seen on the pipeline flex braid (fraying) and pushwire(bending); it is likely high force used during the delivery.It is likely these damages occurred when the customer attempted to advance and retrieve the pipeline flex sheild through the phenom 27 catheter against 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
• 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: 17650998
• MDR Text Key: 322290241
• Report Number: 2029214-2023-01528
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284145
• UDI-Public: 00763000284145
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-350-12
• Device Catalogue Number: PED2-350-12
• Device Lot Number: B539620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2023
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 97 KG