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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FA-77325-14
Device Problem Delamination (2904)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/22/2016
Event Type  Malfunction  
Manufacturer Narrative

The pipeline pushwire was returned for evaluation without the braid as it was implanted in the patient. No damage was found with the tip coil, capture coil or proximal bumper. Flaking of the pushwire coating was observed inside the capture coil. Coating integrity of the entire pushwire length was examined under a video inspection system. The coating was found intact except at sections approximately 14 to 24 cm and 41 to 58cm from the distal tip coil as well as 10 to 23cm from the proximal end. This event investigation is ongoing. A follow-up mdr will be submitted once investigation is complete. 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 pushwire coating "sloughing" during a procedure. The patient was undergoing treatment for a recurrent basilar tip aneurysm; the aneurysm had previously been clipped. The aneurysm was unruptured and saccular. The max. Diameter was 12mm and neck diameter was 8mm. Landing zone artery size was 2. 5mm distal and 3. 1mm proximal. Vessel tortuosity was moderate. All devices were prepared as indicated in the ifu. The pipeline braid was successfully deployed and the pushwire was removed from the patient. It was reported that upon removal, the physician noticed "sloughing" of the pushwire's hydrophilic coating. The sheath was aspirated in order to ensure that nothing remained in the patient. There were no reports of patient injury or symptoms in connection with this event. The post-procedure angiographic result showed excellent flow through the pipeline and distal vessels.

 
Manufacturer Narrative

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.

 
Manufacturer Narrative

Additional information, device evaluation based on the analysis findings and event description, the report of coating removal during use was confirmed as the ptfe coating on the pushwire was found to be delaminated.

 
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Brand NamePIPELINE 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 Key5984596
MDR Text Key55885582
Report Number2029214-2016-00840
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 09/29/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/28/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/11/2017
Device MODEL NumberFA-77325-14
Device LOT NumberA071095
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/27/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/12/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number2029214-10/7/16-001-R

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