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

Model Number PED3-027-550-30

Device Problem Activation Failure (3270)

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

Event Date 09/21/2021

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 vantage mid-segment was not opening in the curve.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right ica (internal carotid artery) with an unknown max diameter and an unknown neck diameter.It was noted the patient's blood flow was unknown and vessel tortuosity was moderate.It was reported that the pipeline vantage mid-segment was not opening in the curve.Different positions were attempted to open the middle segment, but the pipeline failed to open.The pipeline was not positioned in a bend.Less than 50% of the pipeline had been deployed when it failed to open.It was unknown how many times the pipeline was resheathed.No additional steps were required to open the pipeline.The pipeline was removed from the patient.The pipeline was resheathed and removed with the microcatheter.It was unknown if the patient had any symptoms or complications associated with this event.It was unknown if the dapt (dual antiplatelet treatment) was administered.The angiographic results showed good wall position and stase in the aneurysm.The pipeline and accessories were prepared as indicated in the ifu.Ancillary devices include a phenom plus guide catheter, phenom 27 guidewire, and a synchro.

Manufacturer Narrative

Product analysis: as found condition: the pipeline vantage device was returned for analysis within a shipping box; within two sealed plastic biohazard pouches; within an opened pipeline vantage outer carton and within an opened pipeline vantage inner pouch.The already deployed braid was returned within the same inner pouch.The phenom-27 micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the proximal pusher.The hypotube was found intact and unstretched and ptfe shrink tubing was still intact.No damages were found with the spacers or proximal bumper.The proximal supporting disk was found damaged.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No damages or irregularities were found with the tip coil.The braid was already deployed.Both braid ends were found fully opened, damaged and frayed.The middle braid was found fully opened and slightly flattened.No other damages were observed.Testing/analysis: n/a conclusion: based on the analysis findings, the customer report of ¿failure/incomplete open at middle section (hourglass shape)¿ could not be confirmed through device analysis as the returned braid was found fully opened.Possible causes include patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid was overstretched during delivery, user deploys braid in vessel bend, presence of other indwelling endovascular stents, or improper anatomy.The braid was found damaged.Potential causes for braid damage are resheathing more than 2 times, high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, deploying/resheathing braid against resistance, or damage during return shipping as the braid was returned already deployed and out of its protective introducer sheaths and dispenser coils.Customer reported patient vessel tortuosity as moderate, pipeline was not positioned in a bend, and devices were prepared per ifu.The supporting disk was found damaged, indicative of over-manipulation, high force delivery, patient vessel tortuosity or advancing against resistance.The damaged supporting disk would not have contributed towards the failure to open.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 VANTAGE WITH 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12536600
• MDR Text Key: 282292425
• Report Number: 2029214-2021-01210
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/08/2021

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 Model Number: PED3-027-550-30
• Device Catalogue Number: PED3-027-550-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Female