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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 PED3-027-450-20
Device Problems Material Deformation (2976); Activation Failure (3270)
Patient Problem Pain (1994)
Event Date 06/08/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding two pipeline devices used in a procedure, one with mid-section apposition issues and the second which was flattened.It was reported that the first pipeline vantage device (4.5 x 20) was delivered but in the second turn during deployment the device appeared flattened in the mid-section and was not well-apposed to the patient's vessel walls.The device was removed from the patient and discarded.It was replaced with another pipeline vantage (4.5 x 16).This device was delivered just distal to the aneurysm.The device opened well at the distal end and was well anchored.However, during the second turn this device also flattened.The surgeon was able to address the flattening.The device opened up and was well-apposed.Ct angio confirmed the device was open and in the correct location.The surgeon was happy with the deployment and outcome.After the procedure, the patient complained of pain and numbness in their right lower leg which was successfully treated with pain medication.The patient was discharged according to plan without additional medical intervention and no extension of hospitalization.
 
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 received from the manufacturer representative who was present during the procedure reporting that the proximal end of the pipeline vantage device was positioned in a bend.The distal end was in a straight segment and opened well.The surgeon attempted 2-3 times to resheath the pipeline though never completely resheathed and it failed to open.After the first pipeline was replaced and the second device had similar issues and resheathing was also not successful but the surgeon was able to open the device by crossing the microcatheter back through it.Though not confirmed, it was suspected that the patient's vessel tortuosity was the most likely cause of the issue with the pipeline vantage device(s) not opening well.There were no images available for review.
 
Event Description
Additional information received reporting that the patient symptoms had resolved.
 
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.
 
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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
MDR Report Key10155193
MDR Text Key196553222
Report Number2029214-2020-00558
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/04/2022
Device Model NumberPED3-027-450-20
Device Catalogue NumberPED3-027-450-20
Device Lot NumberA942464
Was Device Available for Evaluation? No
Date Manufacturer Received08/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age37 YR
Patient Weight61
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