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

Model Number PED3-027-450-16

Device Problems Unintended Movement (3026); Physical Resistance/Sticking (4012)

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

Event Date 02/03/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information that a ped3 pipeline was stuck in the phenom 27 catheter.The patient was being treated for a ruptured aneurysm.The pipeline was used for an indication of acute usage that is not approved.The devices was prepared as indicated in the instructions for use (ifu).The catheter was flushed continuously with heparinized saline.The pipeline became stuck during deployment.Additional information received reported the lesion was in the left internal carotid artery (ica), multi lobular aneurysm 3 lobes - wide necked small pcom aneurysm due to size and angulation.Vessel tortuosity was severe, proximal leg calcification and stenosis at the common iliac.The patient was recovering fine and was discharged the next day.No symptoms were reported.The resistance was in the distal section of the catheter.It could not re-sheath the device.No damage to the pipeline pushwire or catheter was observed.Physician flared first ped3 stent in m1, dragged back and it fell to far back not covering the neck of aneurysm.Catheter tip would not move when attempting to re sheath, it was also catching the ophthalmic origin.Ped3 4.5 x 16 stent was removed along with phenom 27.2nd stent 4.5x20 opened fine distally, foreshortened a little when recovering delivery system through the stent.Neck of aneurysm is covered by the stent.Physician did not track phenom through the stent as he did not believe it was necessary to do so.Vessel sizing 3.75mm distal and 4.4mm proximal.

Manufacturer Narrative

Product analysis: as found condition (condition of returned device): a pipeline vantage system and a phenom-21 catheter were returned for analysis within a shipping box and within an opened biohazard pouch.Visual inspection/damage location details: the inner diameter (id) of the phenom-27 microcatheter inner diameter was found to be 0.027¿ per ifu (instructions for use).Per pipeline vantage device instructions for use (ifu): ¿the pipeline vantage 021 system is designed to be delivered through a compatible micro catheter of 0.021¿ inside diameter at least 135cm in length.Therefore, the phenom-27 micro catheter was found to be compatible for use with the pipeline vantage.The pipeline vantage system was returned within phenom-21 catheter.The pipeline vantage was found to be extending ~39.2cm from hub and extending ~3.2cm from distal tip.The pipeline vantage was then removed from catheter for further analysis.(pli-10) no bends or kinks were found with the pipeline vantage pushwire.The hypotube and ptfe were found to be intact.The a.R.M.(advanced re-sheathing mechanism) was found to be intact but damaged.No damages were found with the silicone disks.The dps sleeves were found to be intact.The tip coil was found to be intact.Proximal braid end was found to be collapsed and frayed.Distal braid end was found to be opened and appeared to be in good condition.No other anomalies were observed.(pli-20) no flash or voids molded were observed with the hub.No damages or irregularities were found with the distal tip and marker band.The catheter body was found to be accordioned at ~2.0cm from distal tip.The catheter total length was measured and found to be ~158.0cm and the usable length was found to be ~151.5cm.No other anomalies were observed.Testing/analysis (including sem reports): n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿resistance during re-sheathing¿ was confirmed; however, the root cause for the resistance could not be determined.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ was confirmed; however, the root cause could not be determined.Possible contributors for of ¿resistance during re-sheathing¿ and ¿catheter resistance¿ are patient vessel tortuosity, ped/delivery system damage, catheter damage, resistance during delivery/retrieval, and user re-sheaths more than two times.Based on the device analysis and reported information, the customer¿s report of ¿movement during deployment¿ was unable to be confirmed and the root cause could not be determined.Possible contributing factors for ¿movement during deployment¿ are patient vessel tortuosity or high force delivery.The customer reported patient vessel tortuosity as severe.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.

• 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: 13625381
• MDR Text Key: 286578379
• Report Number: 2029214-2022-00327
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2024
• Device Model Number: PED3-027-450-16
• Device Catalogue Number: PED3-027-450-16
• Device Lot Number: B242896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 02/28/2022
• Supplement Dates Manufacturer Received: 04/29/2022
• Supplement Dates FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2021
• 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