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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-425-20
Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2018
Event Type  malfunction  
Manufacturer Narrative
No device return so no product analysis could be performed. The cause of the event was not determined. D. Suspect medical device brand name: pipeline flex with shield technology model number: ped2-425-20 mdrs related to this event: 2029214-2018-00622, 2029214-2018-00623, 2029214-2018-00624. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during deployment of a pipeline product, the device would not open in the middle section. The pipeline devices were not used off-label and were prepared according to their indications for use (ifu). The product was also noted to have been manipulated normally while the middle section of the device was being deployed around a bend. The accessory products included the following: 6fr shuttle sheath, 5fr sophia. It was also confirmed that the patient's anatomy was normal. It was reported that upon deployment of a pipeline stent for a right internal carotid artery (ica) blister / unruptured aneurism, the product did not open more than 50% in the middle section. It was also noted that the product was twisted and flattened out. The product was re-sheathed twice and deployed again without success. The pipeline device was removed from the patient and it was discovered that it was "jammed in the marksman" catheter. Two addition pipeline devices and marksman guide catheters were used but the same issue occurred. An lvis jrn product was then inserted and removed as the event recurred again. There was no known impact or consequence to the patient. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The pipeline flex with shield delivery system stuck inside the marksman catheter was returned for evaluation within its inner pouch; inside of a sealed bio-hazard bag and a shipping box. For further examination, the pipeline flex with shield was then pushed out from the catheter lumen with difficulty. A minimal amount of blood was observed inside the catheter lumen. The distal and proximal dps restraints were found to be intact. The dps sleeves were found intact with no signs of damage. The outer diameter (o. D) of the re-sheathing pad was measured within specifications (0. 5836mm). The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact. The pipeline flex shield braid was found fully opened with moderately frayed at both ends. The pushwire appeared to be bent at 25. 5 cm from the proximal end. No defects were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper. The total and usable lengths of the catheter were measured to be within specifications. The catheter tip and the marker band were examined and no damages were found. The catheter body was found to be stretched and accordioned at 18. 0 cm to 29. 5 cm from the distal tip. No flash or voids molded were observed in the hub. The catheter was flushed with water and found to be patent. The catheter was then tested by running an in-house 0. 0265¿ mandrel through catheter tip and hub. The mandrel could pass through the catheter tip and hub with no issues; however, resistance was observed at the damaged locations. No other anomalies were observed. See related regulatory report 2029214-2018-00622. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was also confirmed that the patient's anatomy was normal and that all three of the pipeline devices acted in the same manner. Upon reflecting on the issue the physician felt the issue had nothing to do with the devices and more likely the anatomy of the vessel. It is believed that there may have been tissue webbing at the point of flattening, but this was unable to be proven.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer Contact
gabriela mclellan
9775 toledo way
irvine, CA 92618
9498373700
MDR Report Key7690507
MDR Text Key114558767
Report Number2029214-2018-00623
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/04/2020
Device Model NumberPED2-425-20
Device Catalogue NumberPED2-425-20
Device Lot NumberA518691
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2017
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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