• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-350-20
Device Problems Positioning Failure (1158); Material Deformation (2976); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/21/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline that failed to achieve successful wall apposition and was found to be damaged.The patient was undergoing a procedure for flow diversion treatment of an unruptured saccular dissecting aneurysm of a posterior communicating artery.The aneurysm max diameter was 5mm and the neck diameter was 4mm.The vessel tortuosity was minimal.Dual antiplatelet treatment (dapt) was administered.It was reported that the pipeline and all accessory devices were prepared as indicated in the instructions for use (ifu).After the catheter was in place, the pipeline was pushed out but could not be secured.The device was recovered redeployed but still could not achieve full apposition.The pipeline was withdrawn and the tip of the pipeline was noted to be rough.The pipeline was replaced by another with the same diameter which was successfully implanted to complete the surgery.There were no patient symptoms or complications associated with this event.Post-procedure angiography after implantation of the replacement pipeline showed blood retention in the aneurysm.Additional information received clarified that the pipeline could open, but could not fully open.The pipeline had been placed in a straight blood vessel and not a bend at the time.There had been no friction/difficulty during delivery.
 
Event Description
Additional information received reported that the distal part of the pipeline did not open.The doctor had tried to "recycle" and redeploy the device to try to get it to open.
 
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.
 
Manufacturer Narrative
H3: the pipeline flex device and phenom-27 micro catheter were returned for analysis.The pipeline flex hypotube was found stretched at the distal end with the ptfe shrink tubing still intact.No damages were found with the resheathing marker, re-sheathing marker or with the proximal bumper.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The tip coil was found intact.No damages or irregularities were found with the phenom-27 micro catheter hub, catheter body, distal tip or marker band.Dried blood was found within the hub.The pipeline flex braid was found within the proximal end of the phenom-27 micro catheter.Both ends of the braid were found fully opened and frayed.The phenom-27 micro catheter total length was measured to be 158.4cm and the usable length was measured to be 151.6cm.As the model and lot numbers were not reported, conformation to specification could not be confirmed.Based on the analysis findings, the customer report of ¿failure/incomplete open distal (flex)¿ could not be confirmed through device analysis.Possible causes are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid was overstretched during delivery, user deploys braid in vessel braid, presence of other indwelling stents or inappropriate anatomy.The customer report of ¿pipeline damaged during delivery/retrieval¿ was confirmed.The braid was found frayed.Potential causes for braid damage are resheathing more than 2 times, high force delivery, over-manipulation, delivering/retracting delivery wire against resistance or de ploying/resheathing braid against resistance.Customer reported all devices were prepared per ifu, pipeline not placed in a bend, no friction was found during delivery and patient vessel tortuosity as minimal.They hypotube was found stretched, indicative of retraction against resistance.The customer report of ¿difficult placement/positioning¿ could not be confirmed through device analysis.P ossible causes are patient vessel tortuosity, braid incorrectly sized to vessel, resistance, other indwelling endovascular stents, braid damaged, braid deployed in vessel bend, micro catheter tip not correctly placed, or braid not anchored correctly.The phenom-27 micro catheter is compatible for use with the pipeline flex.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PIPELINE FLEX
Type of Device
INTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
MDR Report Key12230238
MDR Text Key264166750
Report Number2029214-2021-00932
Device Sequence Number1
Product Code OUT
UDI-Device Identifier00847536015395
UDI-Public00847536015395
Combination Product (y/n)N
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/23/2024
Device Model NumberPED-350-20
Device Catalogue NumberPED-350-20
Device Lot NumberB165628
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2021
Date Manufacturer Received09/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-