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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-350-30
Device Problem Break (1069)
Patient Problems Fistula (1862); Hemorrhage, Cerebral (1889); Foreign Body In Patient (2687)
Event Date 08/08/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the proximal segment of the pipeline flex with shield pushwire was returned for evaluation. The pipeline flex with shield braid remains implanted in the patient and distal segment of the pushwire was left in the patient. The pipeline flex with shield pushwire was found to be separated at the distal hypotube. The hypotube was found to be severely stretched. Kinks or bends were found on the pushwire at a section near the proximal end. The broken end of the pushwire was then sent out for scanning electron microscopy (sem) analysis. Based on the customer¿s photos, analysis findings, reported details, and sem analysis, the reports of failure to resheath and pushwire break were confirmed. The fracture surface features of the broken end are consistent with torsional overload failure. From the damages observed on the proximal wire (kinking/bending) and hypotube (stretching), it appears that excessive force used. It is possible that excessive force used during procedure may have contributed to the reported issues. Per our instructions for use: ¿advancement of the ped against resistance may result in device damage or patient injury. Never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy. If the cause cannot be determined, withdraw the catheter. Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel. ¿ the microcatheter was not returned for evaluation; any contributing factors from the microcatheter other than its inner diameter (id) of 0. 027" could not be assessed. The lot history record of the reported lot number was reviewed and there is no indication that any manufacturing activities have contributed to reported issues. All products are 100% inspected for damage and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The pipeline flex with shield device will not be returned for evaluation as it remains implanted in the patient. The remainder of the pushwire has not been returned for evaluation. Product analysis cannot be performed. The cause of the event could not be conclusively determined from the reported information. Suspect medical device brand name: pipeline flex with shield technology model number: ped2-350-30. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report of pipeline flex with shield pushwire separation and aneurysm rupture during a procedure. It was reported that the patient presented with facial paresis; a bleed in the mesencephalon as well as a large aneurysm (25 x 18 mm) were detected. The patient was to undergo flow diversion treatment for the aneurysm, which was fusiform and located in the left internal carotid artery (ica). The vessel was minimally tortuous. The devices were prepared as indicated in the ifu. During the procedure, the sheath and guide catheter were placed in the ica with a guide catheter. The microcatheter was placed distally. The pipeline flex with shield was advanced through the microcatheter to the m1 middle cerebral artery (mca) and deployment began. The ptfe sleeves were uncovered, then the pipeline flex with shield was partially resheathed and moved to the distal landing zone directly below the bifurcation. The physician attempted to pull the pipeline flex with shield together with the microcatheter more proximally; it was reported that the pipeline flex with shield kicked back falling into the aneurysm. The device was partially resheathed in order to be removed from the patient. After partial resheathing, it was reported that the device could no longer move ¿ not with the catheter nor with the help of the pushwire. It was realized that the pipeline flex with shield pushwire had broken ¿below the bumper. ¿ the pipeline flex with shield braid remained in the patient: the proximal section in the ica and the distal end open in the aneurysm. The physician considered placing a second pipeline device at the distal end of the device, but part of the broken pushwire remained in the vessel media, which would make passage of a guidewire impossible. The physician realized that the aneurysm had ruptured resulting in a carotid-cavernous fistula (ccf). It was reported that the cause of the rupture is not known. All devices were removed from the patient; no further intervention was taken. It was reported that the patient remains in good condition without any neurological deficits. It has since been reported that the bleeding has stopped and the aneurysm has thrombosed.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9496801224
MDR Report Key6836850
MDR Text Key249003276
Report Number2029214-2017-01010
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 10/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/02/2019
Device Model NumberPED-350-30
Device Lot NumberA270826
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2016
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: 08/31/2017 Patient Sequence Number: 1
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