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

Model Number PED3-027-500-16

Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 06/01/2021

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 physician deployed the ped3-027-500-20 pipeline in a straight segment, the distal end opened pe rfectly, but the proximal end was flattened and twisted.Re-sheathing was performed, but the stent still did not open.When attempting to re-sheath for removal into the microcatheter, the stent became stuck in the distal segment of the phenom catheter.After remov al, it was noticed the distal end of the catheter was kinked, but there was no damage to the pipeline pushwire.A ped3-027-500-16 was then delivered and deployed, but the stent experienced the same issue: distal opening was good, proximal segment was flattened and twisted, and became stuck in the microcatheter during removal.There was no damage to the pipeline pushwire, and it was unknown if there was any catheter damage to the second catheter.Replacement products were then used to complete the procedure successfully.It was indicated that all devices were prepared/flushed as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiographic results showed good results.The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm of the ophthalmic segment of the internal carotid artery (ica) with a max diameter of 8 mm and a 5 mm neck diameter.It was noted the patient's vessel tortuosity was severe.It was unknown if dual antiplatelet therapy (dapt) was administered.Ancillary devices include an exelsior xt-27, 1 tip, straight xt270581, infinity / navien 058 guide catheters, fg15150-0615-1s lot fe20-046.

Event Description

Additional information received indicated each pipeline (ped3-027-500-20 and ped3-027-500-16) were re-sheathed up to three times.

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.

Manufacturer Narrative

H3: the pipeline vantage device was returned still within the (stryker) excelsior xt-27 catheter (ref: (b)(4), lot: 22412619).The pusher was extending from within the excelsior xt-27 catheter hub for ~41.5cm.No bends or kinks were found with the excelsior xt-27 catheter body; however, the distal tip was damaged.The pipeline vantage braid was found partially deployed from within the excelsior xt-27 catheter distal tip.The pipeline vantage braid distal end was found open and in good condition.The pipeline vantage pusher eptfe sleeves and tip coil were found in good condition.The pipeline vantage device was pushed out from within the excelsior xt-27 catheter with difficulty causing the catheter to separate.The pipeline vantage pusher was found still intact.The pipeline vantage braid proximal end was found open, but damaged (frayed).However, there was an appearance of dried blood on the pipeline vantage pusher and braid proximal end based on the device analysis and reported information, the customer¿s ¿failure/incomplete open proximal¿ report could not be confirmed as the device has been fully deployed and re-sheathed.In addition, the pipeline vantage braid was found fully open.It is possible the damage found with the pipeline vantage braid and the patient¿s ¿severe¿ vessel tortuosity contributed to the event; however, the cause could not be determined.Regarding the customer¿s ¿resistance during re-sheathing,¿ the report was confirmed.From the damages seen on the excelsior xt-27 catheter distal tip, it appears there was high force used.These damages likely occurred when the pipeline vantage was retracted through the excelsior xt-27 catheter against resistance.Resistance can occur during tracking, deployment, and re-sheathing of the device in distal and tortuous anatomies.It is likely the patient¿s ¿severe¿ vessel tortuosity contributed to the reported resistance.In addition, as per the pipeline vantage ifu (instructions for use), ¿the pipeline vantage 027 system is designed to be delivered through a compatible micro catheter of 0.027 inch (0.69 mm) inside diameter at least 135 cm in length.¿ the excelsior xt-27 catheter has a labeled id (inner diameter) of 0.027¿, as per an online source.Therefore, the excelsior xt-27 catheter appears to be compatible for use with the pipeline vantage device.The investigation determined that these events were similar to events that had already been investigated, and another investigation is not necessary.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
• MDR Report Key: 11957303
• MDR Text Key: 254913697
• Report Number: 2029214-2021-00692
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED3-027-500-16
• Device Catalogue Number: PED3-027-500-16
• Device Lot Number: B193164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR