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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 LASER THERAPY PRODUCT

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY LASER THERAPY PRODUCT Back to Search Results
Model Number PED2-500-20
Device Problem Activation Failure (3270)
Patient Problem Vasoconstriction (2126)
Event Date 09/09/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the distal segment of the pipeline failed to open. The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm of the right internal carotid artery cavernous s egment with a max diameter of 12. 6mm and a 6. 4mm neck diameter. It was noted the patient's vessel tortuosity was moderate. It was reported that there was easy access and placement of the microcatheter at the target location. Delivery of the pipeline in the microcatheter and to the landing zone was easy. The distal part of the pipeline opened very slowly, and a lazy opening happened until 1/3 of the device was unsheathed. The pipeline was resheathed in the microcatheter by pushing the catheter distal over the sleeves. The sofia was brought over the pipeline while it was unsheathed. The physician then started to deploy the pipeline further, and this was done easily and opened good. The proximal segment also opened very easily. The physician thought they could fix the distal segment of the pipeline by giving it a massage with a j-shaped microwire or a balloon dilation, but this was not possible. It was noted the device was not positioned in a bend, resheathing was performed more than twice, and more than 50% of the device had been deployed when it failed to open. The balloon angioplasty failed, and wall apposition was not attained. However, the pipeline was implanted at the intended location with at least 3mm past the neck on each side of the aneurysm. It was also stated the pipeline missed the landing zone, and the catheter tip moved during deployment. There would be 24 hour follow-up performed, and control with a new angiography. Dual antiplatelet therapy (dapt) was still on the protocol. The pipeline was not prepared per the instructions for use (ifu): the backflush on the pipeline protector hub was not done. It was unknown if there was any patient symptoms or complications associated with the event, but post-procedure angiographic results showed no stasis, occlusion, or thrombosis in the artery. There was very limited spasm proximal in the internal carotid artery. Ancillary devices include a sofia plus 115cm, headyway27, traxcess 14, hyperform.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
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 Key10520832
MDR Text Key207054323
Report Number2029214-2020-00915
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-500-20
Device Catalogue NumberPED2-500-20
Device Lot NumberA911795
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 Received09/11/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/09/2019
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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