• 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 W/SHIELD TECHNOLOGY 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 W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-325-20
Device Problems Retraction Problem (1536); Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/04/2022
Event Type  malfunction  
Event Description
Medtronic received information that a phenom catheter had resistance in the distal portion causing the pipeline flex stent to migrate. The patient was being treated for an unruptured fusiform aneurysm in the left cerebellar location. It was a brain aneurysm embolization.  the max diameter was 5mm and the neck diameter was 4mm. The distal landing zine was 2. 25mm and the proximal landing zone was 3. 20mm. Vessel tortuosity was moderate. The access vessel was the vaina shuttle and the diameter was 3. 5mm the devices were prepared according to the instructions for use (ifu).   the stent was positioned correctly, with optimal distal opening at a 2. 25mm segment, and optimal proximal opening. At the time of performing the recapture maneuver of the distal tip, the phenom microcatheter was advanced to the distal area and it was observed that the ptfe wings were not completely recaptured and when the phenom microcatheter was retracted it was noted that it pushed the device to the neck of the aneurysm that herniated in it, at that moment the system was withdrawn and another phenom microcatheter was used that was advanced inside the pipeline inside the aneurysm until it crossed distal to the m1 segment, then another pipeline device of 3. 0 x 25 mm was implanted, what was it it was positioned distally and an optimal opening was made by telescoping the device that failed, without drawbacks and covering the neck of the aneurysm.  the device migrated in its distal portion towards the neck and later into the aneurysm, this occurred because the push guide got stuck in the distal end of the microcatheter when trying to recapture the ptfe wings. The pipeline was implanted at the intended location. Full wall opposition was achieved. Side branches were not cove red by the pipeline as pushwire/capture coil stuck during retraction. The catheter was damaged. It was accordioned. The catheter was stretched in the distal section during removal. Force was applied during removal the catheter tip was stuck. There was no vaso spasm. The pushwire was not damaged. A second pipeline was implemented to correct the fault. Dual antiplatelet treatment was administered.  pru level prasugrel + aas. Angiographic result after the first implant: device with distal area inside the aneurysmal sac. Result after the second implant: devices covering the neck and wall correctly. No symptoms were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIPELINE FLEX W/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 Key13581997
MDR Text Key290796763
Report Number2029214-2022-00265
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
P100018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-325-20
Device Catalogue NumberPED2-325-20
Device Lot NumberB148521
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-