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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-400-18
Device Problems Difficult To Position (1467); Physical Resistance (2578); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/23/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The pipeline flex with shield device has not been returned for evaluation. The reported event could not be confirmed and an event cause could not be conclusively determined from the reported information. It should be noted that the pipeline flex with shield instructions for use (ifu) provide the following precaution: do not place the pipeline flex embolization device with shield technology in patients whom a pre-existing stent is in place in the parent artery at the target aneurysm location. Suspect medical device brand name: pipeline flex with shield technology, model number: ped2-400-18. 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 that a pipeline flex with shield did not open during a procedure. The patient was undergoing treatment for a previously-treated aneurysm in the posterior communicating (pcom) artery. Eighteen months prior, the aneurysm had been treated using coils and a stent. The aneurysm max. Diameter was 5mm and neck diameter was 4mm. The landing zone artery size was 3. 7mm distal and 3. 9mm proximal. Vessel tortuosity was normal. The devices were prepared as indicated in the ifu. A continuous heparinized saline flush was used during the procedure. The aneurysm had recanalized and the patient was undergoing retreatment. It was reported that there difficulty navigating a pipeline flex with shield and microcatheter through the existing stent. At deployment, the pipeline flex did not open in the distal section. The system was removed from the patient. The procedure was completed using coils. There were no reports of patient injury in connection with this event.
 
Manufacturer Narrative
The pipeline flex with shield was returned for evaluation. As received, the device was within the catheter and was pushed out of the catheter for further examination. The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact. The distal end of the pipeline braid was found fully open with moderate fraying, while the proximal end was found fully open with no damage. Based on the analysis findings, the report of pipeline flex with shield failure to open at the distal end could not be confirmed. It is possible that the damaged braid may have contributed to the reported issue, however, the cause for damage could not be conclusively determined. In addition, it is possible that the presence of the pre-existing stent may have interfered with proper deployment and function of the pipeline flex with shield device. Additionally, the damage observed on the pipeline braid (fraying) and hypotube (stretching) suggests that excessive force was used during delivery (pushing <(>&<)> pulling). Per our instructions for use (ifu): ¿do not place the pipeline flex embolization device in patients whom a pre-existing stent is in place in the parent artery at the target aneurysm location. The presence of other indwelling endovascular stents may interfere with proper deployment and function of the pipeline flex embolization device. Discontinue delivery of the device if high force or excessive friction is encountered during delivery. Identify the cause of the resistance and remove device and microcatheter simultaneously. Advancement of the ped against resistance may result in device damage or patient injury. Never advance or withdraw an intralumenal 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. ¿ all products are 100% inspected for damage and irregularities during manufacture.
 
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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 Key6419732
MDR Text Key107405146
Report Number2029214-2017-00205
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUK
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 02/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/11/2019
Device Model NumberPED-400-18
Device Lot NumberA275980
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2016
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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