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

Model Number PED3-027-400-20

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

Patient Problems Muscle Weakness (1967); Dysphasia (2195)

Event Date 08/02/2021

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 4x20 stent was taken to the tip of the microcatheter and initially tip coil pushed halfway out.Then the stent was opened distally, the system was drawn back into the internal carotid artery (ica), but the stent was at an awkward angle pointing towards the anterior choroidal.Approximately 1-2 fifths of the stent open resheathed, and repositioned several times.Once the physician was satisfied with the position, more of the device was pushed out, but the vessel narrowed and attempts were difficult.While trying to open the middle and proximal segments, the distal end dropped back and needed repositioning.Eventually a good position was achieved, the mid-section opened through the bend to almost fully deploy.The physician was not satisfied with the final few mm that would deploy into a slightly wider segment and possibly beunopposed to the vessel wall.A 4.5x14 was used instead.However, the same issue occurred: the mid-section appeared to twist.After re-sheathing and repositioning multiple times, the device was removed.A non-medtronic product was used and deployed well.Following deployment of the final stent, on table computerized tomography (ct) was performed, and it appeared the patient had cortical staining (hypoperfusion).The patient was extubated at the end of the procedure, and it took a long time for the patient to respond.Eventually they began coughing with no verbal response, weaker right leg and arm movement.The patient was eventually able to obey commands after a lengthy period of time.Increased fluids were give, and the patient was placed on itu for observation overnight.The patient was undergoing surgery for treatment of an amorphous, ruptured aneurysm of the left ica with a max diameter of 6 mm and a 3.3 mm neck diameter.It was noted the patient's vessel tortuosity was severe.All devices were prepared per the instructions for use (ifu).Ancillary devices include a fabuki 80cm 8f sheath, cat 5 115 cm guide catheter, headway 27, synchro 14, phenom 27 x2.

Manufacturer Narrative

H3.Product analysis: no damages or irregularities were found with the phenom-27 micro catheter hub.The pipeline vantage pusher was found extending out the hub ~39.8cm.The micro catheter tip was found damaged (indentation).No damages or irregularities were found with the marker band.The pipeline vantage tip coil and dps sleeves were found extending out the catheter tip.The pusher was advanced out with no resistance encountered.No damages or irregularities were found with the tip coil.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The hypotube was intact and unstretched and ptfe shrink tubing was still intact.No damages were found with the spacers or advanced re-sheathing mechanism.The braid was already deployed.The entire braid length was fully opened and slightly flattened.Both braid ends were found damaged.Based on the analysis findings, the customer report of ¿failure/incomplete to open at middle section (hourglass shape)¿ could not be confirmed as the braid was found fully opened.Possible causes are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid was overstretched during delivery, user deploys braid in vessel braid, presence of other indwelling stents or inappropriate anatomy.The braids were 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 devices were repositioned several times, devices was deployed in a bend, patient vessel tortuosity as severe, and devices were prepared per ifu.The customer report of ¿movement during deployment¿ typically cannot be confirmed through device analysis and the customer did not submit any images/videos for review.Potential causes are vasospasm, patient vessel tortuosity, high force delivery, catheter kickback, insufficient distal anchoring of braid, or incorrect braid sizing.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.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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12298802
• MDR Text Key: 265808401
• Report Number: 2029214-2021-00995
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED3-027-400-20
• Device Catalogue Number: PED3-027-400-20
• Device Lot Number: B186465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female