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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-425-16
Device Problems Break (1069); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/14/2018
Event Type  malfunction  
Manufacturer Narrative
This is a report for a similar device that is not marketed in the us. Suspect medical device - similar device brand name
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pipeline flex w/shield technology model #
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ped2-425-16 the pipeline flex with shield technology device has not been returned for evaluation; 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 report that a pipeline flex with shield did not open during a procedure. The patient was undergoing treatment for an unruptured, amorphous aneurysm in the right, ophthalmic internal carotid artery (ica). Vessel tortuosity was described as severe. The devices were prepared as indicated in the ifu. It was reported that during the procedure, the pipeline flex with shield was deployed at the target zone, but the proximal section did not open. The physician attempted to "pull on" the system, but the system "broke. " the tip of the microcatheter and delivery wire were used to open the proximal end; full wall apposition was achieved. Afterward, an additional pipeline device was placed. There were no reports of patient injury in association with this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
This was later clarified to note that there was no break. The pipeline was able to be opened and was implanted in the patient. The tip of the microcatheter and delivery wire were used to open the proximal end; full wall apposition was achieved. Afterward, an additional pipeline device was placed.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
MDR Report Key8142819
MDR Text Key130048687
Report Number2029214-2018-01035
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 04/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/30/2021
Device Model NumberPED2-425-16
Device Catalogue NumberPED2-425-16
Device Lot NumberA653657
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2019
Is This a Reprocessed and Reused Single-Use Device? No

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