• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-275-20
Device Problem Material Deformation (2976)
Patient Problems Stroke/CVA (1770); Dysphagia/ Odynophagia (1815); Paralysis (1997); Dysphasia (2195); Obstruction/Occlusion (2422); Cognitive Changes (2551)
Event Date 05/01/2019
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline that was damaged/deformed during implantation and the patient suffered stroke wi th subsequent adverse symptoms. The patient underwent a procedure for flow diversion treatment of an unruptured 6. 0 x 5. 2 x 5. 7 mm saccular aneurysm of the right middle cerebral artery (mca) bifurcation with neck measuring 3. 1mm and a second aneurysm of the internal carotid m2 segment. It was reported that on (b)(6) 2019, the pipeline device was implanted using the device's provided delivery system. After the release of the device, angiography showed no flow, and later slow flow, and the was noted that the pipeline had ¿twisted,¿ ¿prolapsed¿ or ¿invaginated¿ after full deployment, leading to a ¿no flow¿ and then a ¿low flow" in the inferior portion of the patient's vessel. The physician made repeated attempts to retrieve the pipeline device employing two different balloons, a non-medtronic stent retriever, and a solitaire device but without success. Post-operative evaluation later on 1 may 2019 showed that the patient had experienced a stroke intra-operatively with post-operative assessment of no contraction and no movement in the left leg and left arm motor strength; moves not against gravity right leg motor strength; right arm moves against gravity; delayed right pupil reaction to light; pupils not equal round and reactive; and 10 glasgow coma score. Brain ct on (b)(6) 2019 showed expansion of the previously existing right basal ganglia infarct extending into the corona radiata measuring 3. 3 x 1. 2 cm. Assessment at 1259 on (b)(6) 2019 found that the patient had left central facial weakness, 5/5 on right, 0/5 on left/flaccid (significant for left hemiplegia), severe oropharyngeal d ysphagia, and mild to moderate dysarthria of speech and mild to moderate cognitive deficits with fair prognosis for rehab to increase functional communication and cognitive skills. The complaint noted that the patient sustain irreversible neurological brain damage resulting in significant cognitive, motor and sensory deficits, affecting functional and cognitive abilities.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIPELINE FLEX
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 Key11791173
MDR Text Key249749082
Report Number2029214-2021-00550
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2020
Device Model NumberPED-275-20
Device Catalogue NumberPED-275-20
Device Lot NumberA501423
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 Received06/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/02/2017
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: 05/07/2021 Patient Sequence Number: 1
-
-