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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 INTRACRANIAL ANEURYSM FLOW DIVERTER

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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); Material Deformation (2976); Unintended Movement (3026); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/19/2020
Event Type  malfunction  
Manufacturer Narrative
The react-71 catheter was returned for analysis within a shipping box; within a tyvek bio-pouch; within a plastic bio-pouch and within a re-sealable plastic bio-pouch. The react-71 catheter total length was measured to be 145. 0cm and the useable length was measured to be 138. 0cm which is not within specification (specification: 132cm +3/-0cm). No damages or irregularities were found with the react-71 hub. No bends or kinks were found with the react-71 catheter body. However, the react-71 catheter body was found stretched from 33. 5cm to 29. 0cm from the distal end. Upon microscopic inspection, the catheter inner wire was found intact. The react-71 distal marker/tip was found separated from the catheter. The tubing material of the separated end exhibited with stretching, necking and jagged edges with the inner braid exposed. No other anomalies were observed. Based on the device analysis and reported information, the customer¿s report of ¿catheter accordion¿ was confirmed. The react-71 catheter body was found stretched and the distal marker/tip was found separated from the catheter. The react-71 catheter appears to have been stretched for -8cm. The broken end of the catheter exhibited with plastic deformation (jagged edges and stretching) which indicated that the catheter separated when exceeding the tensile strength of the tubing material. Possible causes for the event could be attributed to tortuous anatomy and/or other contributing factors such as kink/damage in guide catheter / balloon guide catheter /guidewire/stents which can cause the react-71 catheter to become damaged. It is unlikely for the distal shaft to become separated without experiencing excessive resistance. In addition, hard clots /calcifications in the navigation tract can snag the catheter causing damage, resistance, and subsequent separation. However, there is insufficient information to determine the cause of the damages found with the returned react-71 catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pipeline flow diverting stent (ped2-325-20, lot a822938) was deployed without any problem. However, when capturing the delivery wire, the tip coil did not enter inside the microcatheter, and the stent dropped when the system was removed: the distal part of the stent stayed on the aneurysm neck. There was no friction, the pipeline did not miss the landing zone or jump, the stent was placed at least 3 mm on each side of the aneurysm neck, and the ophthalmic artery side branch was covered. As a result, a second pipeline stent (ped2-350-16, lot a859164) had to be deployed in the distal zone of the artery, telescoping the first one. The second pipeline was deployed without any issue, using the same marksman microcatheter. When observing the delivery wires, it was noticed that the ptfe sleeves of the first stent are apparently deformed and it could have prevented the tip coil to enter inside the microcatheter. When comparing both delivery wires, we can see that the distal tip coil of the second stent is more smooth. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. Post-procedure angiographic results were ok. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left internal carotid artery with a max d iameter of 5 mm and a 3. 5 mm neck diameter. It was noted the patient's vessel tortuosity was normal. Dual antiplatelet therapy (dapt) was administered. Ancillary devices include a fargo max 070 guidecatheter, marksman microcatheter, avigo guidewire.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10896652
MDR Text Key219522090
Report Number2029214-2020-01176
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2020
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 NumberA822938
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/30/2019
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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