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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY LASER THERAPY PRODUCT

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY LASER THERAPY PRODUCT Back to Search Results
Model Number PED2-375-20
Device Problems Break (1069); Unintended Movement (3026); Physical Resistance/Sticking (4012)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that two pipeline devices and phenom catheters had movement during placement due to the size of the aneurysm. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right internal carotid artery with a max diameter of 35mm and a 14mm neck diameter. It was noted the patient's vessel tortuosity was severe. Dual antiplatelet therapy (dapt) was administered, but the pru level was unknown. It was reported that everything was set up per the instructions for use (ifu), but the size of the aneurysm was too big. When all the devices were in the right position, all of the system fell down, and when the physician tried to recapture the pipeline device, both products got stuck. It was stated this happened with both pipeline and microcatheters attempted to be used to treat the patient. There was no friction or difficulty during delivery or placement, the landing zone was not missed, there was no device jumping, the pipeline was not implanted to cover the aneurysm, and the tip of the catheter moved during deployment. However, it was also stated the bodies of the catheters were entrapped and/or experienced difficult removal with the pipeline devices. The patient did not experience any vasospasm, and there was no medical or surgical intervention required. There was no patient symptoms or complications associated with the event. Ancillary devices include a fargomax + iva80, balt company. Additional information received reported that resistance was in the distal part of the catheter in both cases. The physician had tried to recapture the device and when they felt the pipeline got stuck, they began to recover all of the system for safety and the pipeline released in the catheter. The second device was pulled out with no criteria by the assistant, which is why the pusher was not in the right place. No damage was observed during the procedure, but when they tried to pull back the second device, the assistant pulled too hard and broke the pusher. The procedure was completed by filling the aneurysm with coils.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
Type of DeviceLASER THERAPY PRODUCT
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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10597983
MDR Text Key208950353
Report Number2029214-2020-00977
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/25/2021
Device Model NumberPED2-375-20
Device Catalogue NumberPED2-375-20
Device Lot NumberA666755
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/26/2018
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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