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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
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.
 
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Brand NamePIPELINE VANTAGE WITH SHIELD TECHNOLOGY
Type of DeviceINTRACRANIAL 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 Key13114309
MDR Text Key291293206
Report Number2029214-2021-01682
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodePL
Number of Events Reported1
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 Received12/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED3-027-450-16
Device Catalogue NumberPED3-027-450-16
Device Lot NumberB265232
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
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

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