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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX LASER THERAPY PRODUCT Back to Search Results
Model Number PED-500-16
Device Problem Activation Failure (3270)
Patient Problems Death (1802); Hemorrhage, Subarachnoid (1893); Discomfort (2330)
Event Date 09/10/2020
Event Type  Death  
Manufacturer Narrative
Refer to manufacturer report 2029214-2020-00926 for details pertaining to the related reportable event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that two pipelines failed to open, but the second one was opened with balloon angioplasty. The patient experienced extravasation in the subarachnoid space. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left cavernous internal carotid artery pa ra-ophthalmic segment. It was noted the patient's vessel tortuosity was normal. Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was unknown. It was reported that the 5x16 pipeline (pli-10) was attempted to be deployed, but it failed to open in the middle segment. The first pipeline was removed, and a replacement (pli-20) size was chosen of 5x20, but the pipeline was deemed too long. The second pipeline was removed, and a third pipeline (pli-30) of 5x16 was delivered. The distal end of the third pipeline failed to open. It was noted the device was not positioned in a bend, more than 50% of the pipelines were deployed when they failed to open, and the third pipeline was resheathed less than three times. A balloon was inserted across the pipeline and inflated. No contrast was visualized in the balloon, and full wall apposition was achieved. The patient demonstrated discomfort, the balloon was removed, angiography was performed and extravasation was seen. The patient was intubated, ventriculostomy was performed, and the patient was taken to ct. The patient was then returned to ir where additional angiography was performed and then taken to surgery with hemorrhage. It was noted all devices were prepared per the instructions for use (ifu). Post-procedure angiographic results showed extravasation into the subarachnoid space and occluded left internal carotid artery. The manufacturing representative (rep) stated there was a high likelihood of a patient death, but they were currently unable to reach the physicians involved. Ancillary devices include two phenom 27, synchro soft, synchro standard, scepter xc. Refer to manufacturer report 2029214-2020-00926 for details pertaining to the related reportable event.
 
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Brand NamePIPELINE FLEX
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 Key10532930
MDR Text Key206960647
Report Number2029214-2020-00927
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-500-16
Device Catalogue NumberPED-500-16
Device Lot NumberB021204
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 Received09/10/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/14/2020 Patient Sequence Number: 1
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