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

Model Number PED2-475-35

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

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

Event Date 09/20/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information that three pipeline stents became twisted and failed to open.The patient was being treated for an unruptured saccular aneurysm.The max diameter was 6mm.The neck diameter was 4mm.The distal landing zone 4.2mm and the proximal landing zone was 4.5mm.Vessel tortuosity was moderate.All devices were prepared as according to the instructions for use (ifu).  while introducing pipeline shield 4.75x35 through marksman microcatheter it was twisted at the beginning with failure to be straighten after resheathing technique was used it also failed and another stent used with another microcatheter.The failure to open on the pipeline was on the proximal end.After failure to open the first stent another stent 4.75x20 was introduced through excelsior xt-27 microcatheter the stent was also twisted at its middle part with failure to overcome this twist with resheathing technique.The failure to open was in the middle section.After the failure of the previous two stents this stent pipeline shield 4.5x35 was introduced through excelsior xt-27 it was twisted from its distal end with multiple failed trials to straighten the stent.The failure to open was on the distal end.The pipelines were not positioned in a bend.They were not stuck in the capture coil.Less then 50% of the pipelines were deployed when it failed to open.The pipelines were resheathed more than 2 times.The pipelines was removed from the patient with the microcatheters.  no symptoms were reported.Dual antiplatelet treatment was administered.  ancillary devices: cordis 8f sheath, guider softip 8f guide catheter, marksman microcatheter, synchro 14 guidewire, excelsior xt-27 microcatheter.

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

The pipelines were resheathed less than or equal to 2 times.

• 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: 12533869
• MDR Text Key: 273383855
• Report Number: 2029214-2021-01206
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P100018.S026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2023
• Device Model Number: PED2-475-35
• Device Catalogue Number: PED2-475-35
• Device Lot Number: B088394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2021
• Date Device Manufactured: 09/18/2020
• 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: 84 YR
• Patient Sex: Female