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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-400-18
Device Problems Deformation Due to Compressive Stress (2889); Positioning Problem (3009); Activation Failure (3270)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 07/12/2018
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 the marksman catheter was deployed until the m1, after which they then delivered and started to open the pipeline at the m1 segment. At this point the most distal part of the pipeline didn't open so they resheathed the device. They then made another attempt during which the device opened with the system pulled until the ica, where the pipeline fell down into the aneurysm neck. The physician tried to resheath and reposition the device but was unable to, so they advanced the navien catheter near the to the proximal of the aneurysm and pulled the marksman and pipeline together into the navien and removed them from the patient. The marksman was checked afterwards which showed that it had deformed like an accordion, with distal stretch damage during removal noted. The case was continued with a new marksman and pipeline with the surgery finishing smoothly. The patient was undergoing surgery to treat an unruptured aneurysm at the left ica with a max diameter of 3. 25 x 3. 55 mm and a neck diameter of 2. 42 mm. The landing zone artery size was 3. 85 mm distal and 4. 08 mm proximal, with a severe vessel tortuosity noted. The catheter was confirmed to be flushed continuously with herapanized saline and dual antiplatelet treatment was administered with a pru level of 129. The catheter tip was not entrapped or stuck and the angiographic result post procedure was normal. There were no related patient symptoms.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received clarified that when the pipeline fell down during opening maneuvers the physician tried to re-sheath and move it a little but forward, but the re-sheathing caused the catheter accordion. It was also clarified that during opening maneuvers the system moved down and the distal tip of the pipeline moved to the aneurysm neck which is why the physician attempted to re-sheath and move forward, causing the pipeline falling into the aneurysm neck/inability to deploy.
 
Manufacturer Narrative
The pipeline flex with shield stuck within the distal segment of the marksman catheter was returned for evaluation; within its inner pouch and a bio-hazard bag; inside of a shipping box. For further examination, the pipeline flex with shield was then pushed out from the catheter lumen with difficulty. A minimal amount of blood was observed inside the catheter lumen. The distal and proximal dps restraints were found to be intact. The dps sleeves were found intact with no signs of damage. The outer diameter (o. D) of the re-sheathing pad was measured to be within specifications (od
=
~0. 5836mm). The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact. Kinks and bends were found on the pushwire at 18. 5 cm to 29. 5 cm from the proximal end. The distal and proximal ends of the pipeline flex shield braid fully opened and moderately frayed. No defects were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper. The total and usable lengths of the catheter were measured to be within specifications. The catheter tip and the marker band were examined and no damages were found. The catheter body was found to be flattened at 5. 0 cm to 10. 5 cm; and accordioned at 19. 5 cm to 30. 5 cm from the distal tip. No flash or voids molded were observed in the hub. The catheter was flushed with water and found to be patent. The catheter was then tested by running an in-house 0. 0265¿ mandrel through catheter tip and hub. The mandrel could pass through the catheter tip and hub with no issues; however, resistance was observed at the damaged locations. No other anomalies were observed. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer Contact
gabriela mclellan
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7756677
MDR Text Key116860868
Report Number2029214-2018-00698
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeTU
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,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/23/2020
Device Model NumberPED2-400-18
Device Catalogue NumberPED2-400-18
Device Lot NumberA434460
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2017
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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