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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 PED2-500-35
Device Problems Retraction Problem (1536); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2020
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex embolization device and phenom 27 catheter were returned for analysis. The pipeline flex embolization device was returned within the phenom 27 catheter. The pipeline flex embolization device was removed from within the phenom 27 catheter without issue. The pipeline flex distal hypotube was found bent and stretched with the ptfe shrink tubing pulled back from the proximal bumper. The pipeline flex resheathing pad and marker were found in good condition. The pipeline flex pusher ptfe sleeves were found damaged. The pipeline flex tip coil was found to be in good condition. The pipeline flex braid was not returned as it remains within the patient. The phenom 27 catheter was then examined. The phenom 27 catheter total length was measured to be 157. 0cm and the useable length was measured to be 150. 5cm. No damage was found with the phenom 27 catheter hub. The phenom 27 catheter body was found accordioned from 10. 0cm to 5. 0cm from the distal tip. The phenom 27 distal tip was found damaged (indented). No other anomalies w ere observed. Based on the device analysis and reported information, the customer¿s reports of ¿delivery system stuck during retraction¿ and ¿pipeline damaged during delivery/retrieval¿ were confirmed as the pipeline flex pusher ptfe sleeves and phenom 27 distal tip were found damaged. However, the cause for the resistance could not be determined. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding resistance during retrieval of a pipeline delivery system with a damaged ptfe sleeve through a phenom-27 microcatheter. The patient was treated for an unruptured c4-c5 saccular aneurysm. The aneurysm max diameter was 11mm and the neck diameter was 11mm. Vessel tortuosity was minimal. Dual antiplatelet treatment (dapt) was administered. It was reported that the pipeline was prepared according to the instructions for use. After the pipeline was successfully implanted, the pushwire could not be pulled back into the phenom-27 microcatheter. The devices were removed without further issue or action. It was noted that the pipeline protective sleeve was bent, preventing the retrieval through the catheter. There was no harm or injury to the patient. Post-operative angiography revealed no problem.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key11449230
MDR Text Key238836686
Report Number2029214-2021-00276
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-500-35
Device Catalogue NumberPED2-500-35
Device Lot NumberB043140
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/19/2020
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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