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 Activation, Positioning or Separation Problem (2906); Unintended Movement (3026)

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

Event Date 12/17/2021

Event Type  malfunction  

Event Description

Medtronic received information regarding a pipeline vantage with shield that failed to open in the middle section during the procedure and a second pipeline that required balloon angioplasty to open but then had movement when opening.The patient was undergoing a procedure for flow diversion treatment of an unruptured saccular aneurysm.Vessel tortuosity was moderate.It was reported that the pipeline vantage (model: ped3-027-450-20, lot: b280292) was deployed and the distal segment opened properly at the neck of the aneurysm but the remaining stent was not opening optimally in the vessel bend.Several attempts were made to resheath and redeploy the stent but it still appeared twisted in the middle at the bend.Therefore, the pipeline was removed and once removed from the patient and pulled out of the catheter, it appeared to open normally.A new pipeline vantage (model: ped3-027-450-16, lot: b265232) was then used.The stent behaved just as the first stent had, twisting during deployment and no opening well at the proximal end.It was attempted to massage the proximal end of the pipeline stent with the catheter tip to attempt to coax it open but this was not successful.Balloon angioplasty was then performed and the stent did open and achieve apposition.However, during the maneuvers the position of the distal end of the pipeline stent was lost and as a result, aneurysm neck coverage was not achieved.It was noted that more than 50% of the pipeline had been deployed when the failure to open occurred.The pipeline was resheathed more than 2 times.No side branches were covered by the patient.The tip of the catheter was moved during deployment.The pipeline remains in the patient who was noted to be doing well and did not have any symptoms or complications associated with the event.

Manufacturer Narrative

See manufacturer report # 2029214-2021-01681 for the first pipeline involved in this event.If information is provided in the future, a supplemental report will be issued.

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

Additional information was received indicating the aneurysm bag had been coiled and the stent opening was not optimal.When passing through the bend, it was difficult to open the stent.Several attempts were made to assemble the stent in front of the bend and reassemble it, however, this was not successful as the stent still looked as if it was twisted in a bend.The stent was withdrawn from the patient and placed in the phenom microcatheter.After the procedure, the stent was removed from the microcatheter and turned out to be normal.Then an attempt was made to treat the pipeline vantage size 450-16.It appeared the second stent behaved exactly the same way as the previous stent.The stent within the bend looked as if it would not open.In this case, however, it was decided by the operator to release the stent although this did not make a difference as it still did not open at the bend.Instead, the proximal part slightly opened.There wasa successful insertion of the phenom microcatheter into the lumen of the stent and measures referred to as "microcatheter massage" were undertaken.This, however, did not bring a desired result as the stent was still constricted at the height of the bend.Therefore an attempt was made to introduce the guidewire and retract the microcatheter.A balt balloon was therefore introduced to support the stent opening.After several attempts to inflate the balloon, the stent was successfully dismantled, but unfortunately the stent jumped afterwards as a result of which the neck of the aneurysm was exposed and the stent descended proximally below the neck of the aneurysm.The final result of the case was that the stent remained in the patient, not constricting the vessel lumen but also not fulfilling the purpose of the aneurysm.The patient was doing well at the time of the report.

• 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: 13114309
• MDR Text Key: 291293206
• Report Number: 2029214-2021-01682
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED3-027-450-16
• Device Catalogue Number: PED3-027-450-16
• Device Lot Number: B265232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• 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: 48 YR
• Patient Sex: Female