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 SeparationProblem (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.

• 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

• Type of Report: Initial,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

0 Patients were 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

• 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
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial