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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-375-18
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Occlusion (1984); Therapeutic Response, Decreased (2271)
Event Date 04/10/2017
Event Type  Injury  
Manufacturer Narrative
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 was implanted in the patient. Based on the provided photos, the report of migration after deployment was confirmed. The device was not returned for analysis, therefore the event cause could not be conclusively determined. All products are 100% inspected for damages and irregularities during manufacture. It is possible that braid sizing and the patient¿s severely tortuous vessel anatomy may have contributed to the reported issue. The pipeline flex with shield instructions for use (ifu) provides the following guidance: ¿choose an appropriately sized pipeline flex embolization device with shield technology such that its fully expanded diameter is equivalent to that of the largest target vessel. An incorrectly sized pipeline flex embolization device with shield technology may result in inadequate device placement, incomplete opening, or migration. Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis. ¿ d. Suspect medical device brand name: pipeline flex with shield technology model number: ped2-375-18 mdrs related to this event: 2029214-2017-00626 2029214-2017-00627 2029214-2017-00628.
 
Event Description
Medtronic received report that three pipeline flex with shield devices migrated after placement. The patient was undergoing treatment for an unruptured, saccular aneurysm in the ophthalmic internal carotid artery (ica). The aneurysm measured 20mm x 18mm. The landing zone artery size was 3mm distal and 3. 9mm proximal. The vessel was severely tortuous. The devices were prepared as indicated in the ifu. It was reported that a pipeline flex with shield (ped2-375-20, lot a356814) was deployed without issue. After detaching the device, the braid migrated proximally leaving the aneurysm neck uncovered. A second pipeline flex with shield (ped2-375-18, lot a358492) was placed and the same issue occurred ¿ the braid migrated proximally. A third pipeline flex with shield (ped2-350-18, lot a349240) was placed without any issue. Afterward, the physician began coiling the aneurysm using the jailed microcatheter technique. At that time, the third pipeline flex migrated within the first two pipeline devices. The physician completed embolization by placing 28 coils, then embolized the artery. The patient¿s flow is reportedly compensated through the other side.
 
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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
Manufacturer (Section G)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9496801224
MDR Report Key6553263
MDR Text Key107029427
Report Number2029214-2017-00627
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIT
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 04/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/12/2019
Device Model NumberPED-375-18
Device Lot NumberA358492
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 Received04/10/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/12/2016
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: 05/08/2017 Patient Sequence Number: 1
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