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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-450-16
Device Problems Break (1069); Activation Failure (3270)
Patient Problems No Known Impact Or Consequence To Patient (2692); Vascular Dissection (3160)
Event Date 08/05/2020
Event Type  Injury  
Manufacturer Narrative

The pipeline flex braid was implanted in the patient. The pipeline flex pushwire has not been returned for evaluation; therefore, product analysis cannot be performed. The device was not returned; therefore, the reported event could not be confirmed. The cause of the event cannot be conclusively determined from the provided information. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received information that the middle segment of the pipeline flex did not open and the distal pushwire separated during a procedure. The middle of the pipeline flex finally opened as the physician manipulated a snare through it to an attempt to capture the separated distal pushwire. The separated distal pushwire was successfully removed from the patient. Post procedure imaging revealed a dissection of the ophthalmic artery with non-restrictive antegrade flow. The pipeline device was patent and apposed, but proximal to the target segment. Immediately one day post procedure, the patient was stable with normal exam findings. The hospital policy dictates they will retain all products used during the procedure. Prior to the event, a phenom 27 was in place in distal m1 with sofia ex as intermediate support catheter and infinity ls as third component of triaxial setup. No difficulty pushing wires and catheters past genus. The pipeline flex was prepped per ifu, advanced smoothly through the phenom, and partially deployed in m1. The distal end opened as system was pulled back into ica to treatment segment. The distal end fully opened as more device was pushed out until it came around the first curve at which point it stopped opening. The wag maneuver was used and the stent opened around the turn and the distal end of stent came back. It was decided to at this time resheath the device to reposition distal end of device. The phenom 27 jumped forward pushing the stent into a cobra head configuration. The phenom 27 and pushwire were pulled back together but there was no corresponding movement seen on the monitor which indicated that the pushwire had fractured proximal to the resheathing pad as the pipeline flex was partially deployed. The pipeline flex had returned to normal shape when the devices were pulled back. The physician retracted the phenom 27 continuing deployment of the pipeline flex. An intermediate catheter was advanced but did not capture the fractured wire. The phenom 27 was removed, and the device was deployed with the sofia ex intermediate catheter. The middle of the pipeline flex eventually opened due distal wire recapture attempts. Multiple attempts were made with various size and styles of snares without success due to the back end of the delivery wire resting against vessel wall. In addition, stent retrievers were used to capture the fractured wire and drag it back into intermediate catheter. During manipulation of wire remnant, the tip coil migrated down into the ophthalmic artery and the back end of the wire changed angles as well. This new angle allowed the snare to capture the wire and rail sofia ex over the delivery wire to the midpoint of the wire. A neuro balloon was inflated inside of the sofia ex to pin the delivery wire inside of the sofia ex. The system (sofia ex, transform balloon) were pulled back and the wire was successfully removed from the patient. Post procedural angiography revealed a dissection of the ophthalmic artery with non-restrictive antegrade flow. The pipeline flex device was patent and apposed, but proximal to the target segment. The patient was undergoing embolization treatment of a unruptured amorphous aneurysm measuring 3. 7mm x 3mm located in the ophthalmic segment of the right internal carotid artery (ica). The distal and proximal landing zone was 3. 26mm x 4. 68mm. The vasculature was moderate in tortuosity. The patient was on dual antiplatelet therapy. The pru level was 177. The pipeline flex distal wire caused dissection. There was not any treatment of dissection. Patient is doing well, at baseline. The pipeline been placed in a vessel bent but final imaging showed pipeline fully open. There was not any friction or difficulty during delivery or positioning. The tip of the catheter was not under stress. The tip of the catheter had no abnormal movement during deployment.

 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10439147
MDR Text Key206962157
Report Number2029214-2020-00825
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPED-450-16
Device LOT NumberA852714
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 Received08/05/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/22/2019
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: 08/21/2020 Patient Sequence Number: 1
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