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

Model Number PED2-500-35

Device Problems Unintended Movement (3026); Activation Failure (3270)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/18/2022

Event Type  Injury  

Event Description

Medtronic received information that a ped2 pipeline stent failed to open in the distal section.The patient was being treated for an unruptured, amorphous aneurysm in the right vertebral artery.The distal landing zone was 5mm and the proximal landing zone was 5mm.Vessel tortuosity was moderate.Dual antiplatelet treatment was administered.  the distal portion of device was not fully open and apposed to the arterial wall of artery.The physician used a micro wire with a ¿j¿ shape on the end to run through the pipeline and open the distal end.As the device was being manipulated the proximal end was pushed into the aneurysm body and the micro wire and micro catheter were ¿flipped¿ out of the pipeline and access was lost.After several attempts the physician was unable to recannulate the device.Blood flow was still observed in the artery and the surgeon elected to leave the device in place and observe it as they considered further treatment options.The distal part of the pipeline was positioned in a bend.More than 50% of the pipeline had been deployed when it failed to open.No additional steps were taken.Full wall apposition was not achieved.Ballooning was not required.Proximal end of device was pushed into aneurysm, blood was still flowing into the vesselpost procedure. device remains implanted; patient may go to surgery for alternate aneurysm treatment.The pipeline was used for an indication that was off-label in the vertebral artery.The devices were prepared as according to the instructions for use (ifu).

Manufacturer Narrative

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

Event Description

Additional information received reported the distal end of the device was around a bend and challenging to navigate to.Once in place, the distal end of the pipeline remained in place but would not fully open.After full deployment, the distal end was still not fully opened.The mid-section and proximal ends were fully opened and across the aneurysm.The physician used the micro-wire to attempt to open the distal end.During the manipulation with the micro-wire, the proximal end of the pipeline moved forward and into the aneurysm.The microcatheter and micro-wire came out of the device and the surgeon was unable to recannulate the pipeline.Bloodflow remained intact and the doctor elected to end the procedure and observe the patient while additional treatment options were considered.The pipeline did not jump and remained in place during deployment.Multiple pipelines were not being used, and the tip of the catheter was not under stress.The catheter tip was not moved during deployment, and the phenom 27 microcatheter performed as expected during delivery.The microcatheter came back as the pipeline was pushed forward during deployment.

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.

• 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: 14508456
• MDR Text Key: 292732499
• Report Number: 2029214-2022-00886
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284756
• UDI-Public: 00763000284756
• 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: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-500-35
• Device Catalogue Number: PED2-500-35
• Device Lot Number: B321078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 05/26/2022
• Supplement Dates FDA Received: 06/21/2022
• Date Device Manufactured: 01/11/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male