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 Unintended Movement (3026); Physical Resistance/Sticking (4012)

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

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer report # 2029214-2021-00992 for the other pipeline device involved in this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that two pipeline devices moved during deployment and could not be resheathed into the phenom 27 microcatheter.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the left posterior communicating artery.The max diameter was 4mm, and the neck diameter was 2mm.The patient's vessel tortuosity was normal.The landing zone was 2.91mm distal and 3.50mm proximal. dual antiplatelet treatment was administered, and the pru level was 161.It was reported that the phenom 27 catheter was advanced into distal m1.During deployment the pipeline device fell back proximal to desired landing zone.The doctor attempted to resheath the device, and it got stuck in microcatheter and she was unable to resheathed.Multiple attempts were made.The guide catheter was advanced and the phenom catheter was manipulated.The doctor was still unable to resheath the pipeline.The pipeline was not deployed and removed from the patient.Another pipeline was used, and during deployment the same issue occurred with the second device.The pipeline was partially open but not deployed and the system fell back proximal to aneurysm neck.The doctor attempted to resheath the device and it was stuck in the phenom catheter.Multiple attempts were made to resheath the device again, and all attempts were unsuccessful.This device was also removed from the patient.Finally, a third pipeline was deployed without incident.There was no injury to the patient and a good angiographic result was achieved post procedure.There was no damage to the pipeline pushwire. the devices were prepared according to the instructions for use (ifu).Ancillary devices include a benchmark 105 guide catheter.

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 was received on 2021-aug-11.It was reported that there was not any difficulty or friction during the initial attempt to deliver the device.  the distal end of the device opened appropriately.  it was only after the device fell back past the intended landing zone and the attempted resheathing that the device got stuck in the phenom 027.  the device did jump during deployment.  it was believed this was due to patient anatomy and guide catheter position.  because the device jumped back below the intended landing zone the resheathing attempt was made. the catheter tip moved during the attempted deployment.  however, the catheter tip must move in order to deploy the device.

Manufacturer Narrative

H3: no flash or voids molded were found within the phenom-027 micro catheter hub.No damages or anomalies were found with the hub.The pipeline flex w/ shield pusher was extending out the hub ~44.2cm.The phenom-027 micro catheter was found accordioned between ~6.3cm and ~9.8cm from the proximal end and accordioned between ~4.6cm and ~1.4cm from the distal end.No damages or irregularities were found with the distal tip or marker band.The pipeline flex w/ shield distal wire and braid were extending out the distal end of the micro catheter.The pipeline flex w/ shield could not be retracted back within the micro catheter and was advanced out distally against resistance.Dried blood was found on the pipeline flex w/ shield device and within the phenom-27 micro catheter.No damages were found with the pipeline flex w/ shield proximal pusher.The hypotube was intact and unstretched and ptfe shrink tubing was found undamaged.No damages were found with the proximal bumper.The resheathing pad, distal marker and re-sheathing marker were found loose on the distal wire.The distal and proximal dps restraints and dps sleeves were found intact.The tip coil was found stretched.Once the dried blood was dissolved, both braid ends were found fully opened, but frayed and damaged.Based on the analysis findings, the customer report of ¿movement during deployment¿ could not be confirmed based on device analysis.Possible causes are vasospasm, patient vessel tortuosity, high force delivery, catheter kickback, insufficient distal anchoring of braid or incorrect braid sizing.The customer report of ¿resistance during re-sheathing/failure to resheath¿ was confirmed as the pipeline flex w/ shield device had resistance within the phenom-27.Possible causes for failure to resheath are patient vessel tortuosity, resistance during delivery/retrieval, ped/delivery system damage, catheter damage, user does not maintain continuous flush, user resheaths more than two times, introducer sheath damaged or introducer sheath not fully seated into the hub.The dried blood could have also contributed towards the resistance.The micro catheter was found accordioned, braid was found damaged, the resheathing marker/distal marker/resheathing pad were found loose on the distal wire and the tip coil were found stretched indicative of retracting the device against resistance.There is no indication that the event is related to a potential manufacturing issue.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: 12294992
• MDR Text Key: 265622072
• Report Number: 2029214-2021-00993
• 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,Followup
• Report Date: 11/18/2021

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: 04/13/2024
• Device Model Number: PED2-350-12
• Device Catalogue Number: PED2-350-12
• Device Lot Number: B190138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 08/11/2021; 11/01/2021
• Supplement Dates FDA Received: 09/08/2021; 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2021
• 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: 45 YR
• Patient Sex: Female