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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 PED2-250-20
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/22/2020
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex embolization device (model: ped2-250-20 lot: a576976) (pli-10) and marksman catheter (model: fa-55150-1030 lot: 217209145) (pli-20) were returned for analysis. The pipeline flex embolization device was returned stuck within marksman catheter. (pli-20) upon visual inspection, no damages were found with the marksman hub or distal tip; however, the pipeline flex pushwire was found extending ~47. 8cm from the hub. The marksman catheter body was found to be accordioned at ~149. 2cm and at ~29. 4cm for ~1. 4cm from distal tip. No damages were found with the distal tip. The marksman total length and useable length were unable to be measured as the catheter was dissected (cut), to remove the delivery system. However, the pipeline flex embolization device was then unable to be completely removed. The marksman micro catheter could not be used for resistance testing with an in-house mandrel due to its damaged condition. (pli-10) the pipeline flex pushwire was found to be kinked at ~39. 4cm and ~41. 6cm from proximal end. The hypotube was found to be stretched with the ptfe pulled back. What appeared to be blood residue was found on the hypotube. The proximal bumper, pad and re-sheathing marker were found intact. The dps restraints/sleeves were found to be intact; however, during analysis they were inadvertently damaged. The tip coil was found to be intact. The proximal end of braid was found to be open and frayed. The distal end of braid was found to be collapsed. No other anomalies were observed. Based on the device analysis and reported information, the customer¿s report of ¿resistance/stuck during delivery¿ was confirmed. The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary. Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies. In addition, resistance can occur due to patient vessel tortuosity, failure to maintain a continuous flush, or pipeline is pulled back/torqued during delivery. The vessel anatomy was moderate in tortuosity. The cause could not be determined. Based on the analysis findings, the customer report of ¿resistance/stuck during delivery¿ was confirmed as the marksman catheter was returned with the pipeline flex embolization device stuck within catheter. The returned pipeline flex braid damages (frayed) are indicative of high force used. It is likely the damage occurred when the customer attempted to advance the pipeline flex through the marksman catheter against the reported resistance. Possible contributors for resistance are patient vessel tortuosity or lack of continuous flush during delivery. Based on the returned devices, there was no non-conformance to specifications identified that led to the resistance during delivery issues. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline that became locked up in a marksman catheter. The patient was being treated for an unruptured saccular aneurysm of an anterior communicating artery. The aneurysm man diameter was 25mm and the neck diameter was 18mm. Vessel tortuosity was moderate. It was reported that the devices were prepared according to the manufacturer instructions for use. The pipeline was inserted into the marksman microcatheter and was being sent for implant but became locked up in the distal end of the marksman and could not be progressed. The system was removed from the patient and a new catheter was used to complete the procedure. The patient did not sustain any harm or injury during the procedure. There was no damage to the pushwire or the microcatheter.
 
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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 Key10814533
MDR Text Key215533531
Report Number2029214-2020-01110
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
Report Date 11/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/04/2021
Device Model NumberPED2-250-20
Device Catalogue NumberPED2-250-20
Device Lot NumberA576976
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/05/2018
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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