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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-400-14
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/16/2016
Event Type  Injury  
Manufacturer Narrative
The pipeline flex remains implanted in the patient and will not be returned for evaluation. The reported event could not be confirmed and the event cause could not be determined from the reported information.
 
Event Description
Medtronic received report that a patient required retreatment after pipeline flex implantation. The patient underwent pipeline flex implantation to treat a saccular aneurysm in the right c6 internal carotid artery (ica). Aneurysm dome was 4. 4mm and neck diameter was 3. 4mm. Seven months post-procedure, it was discovered that the pipeline flex had migrated and foreshortened. There were no reports of patient injury as a result of the migration. One month later, the patient received an additional flow diversion device as a result of the migration.
 
Manufacturer Narrative
Additional information based on information obtained through follow up, the reported device foreshortening was related to the curve in the anatomy and balloon angioplasty procedure to improve wall apposition resulted in 3 mm neck coverage. Over the period of approximately six (6) months, there was straightening of the vessel curvature due to vessel remodeling resulting in the distal end of the device no longer covering the aneurysm neck. Based on our investigation this event is not related to a device failure, rather associated with patient anatomical location and physiological vessel remodeling.
 
Event Description
Medtronic received additional information: the pipeline flex had been deployed in a vessel curve. Balloon angioplasty was used for better wall apposition of the pipeline flex. Immediately post-procedure, the pipeline flex had 3mm of coverage distal to the aneurysm neck. The aneurysm landing zone artery diameter was 3. 15mm distal and 4. 15mm proximal. Seven months post-procedure, the patient underwent a follow up cerebral angiogram to assess the outcome of the pipeline flex implantation. It was reported that the distal end of the pipeline flex no longer covered the aneurysm neck. The angiogram showed that distal neck of the aneurysm was ¿only subtotally covered¿; the pipeline flex appeared to have had ¿interval minimal foreshortening¿. In addition, it was reported that ¿there is a tiny component of the distal device now partially projecting into the neck of the aneurysm. ¿ the physician confirmed that the distal foreshortening of the device was related to the patient¿s anatomy and related to the vessel remodeling of the parent artery. There was no change to the aneurysm size. The patient was asymptomatic. Eight months after the initial pipeline flex implantation, an additional pipeline flex device was placed across the partially exposed neck of the aneurysm. The procedure resulted in flow stagnation within the aneurysm.
 
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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 Key5511010
MDR Text Key40691730
Report Number2029214-2016-00153
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/06/2018
Device Model NumberPED-400-14
Device Lot NumberA054755
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/07/2015
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: 03/18/2016 Patient Sequence Number: 1
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