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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
Device Problems Migration or Expulsion of Device (1395); Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/09/2017
Event Type  malfunction  
Manufacturer Narrative
Peschillo, s. , caporlingua, a. , resta, m. C. , peluso, j. P. , burdi, n. , sourour, n. ,. Resta, m. (2017). Endovascular treatment of large and giant carotid aneurysms with flow-diverter stents alone or in combination with coils: a multicenter experience and long-term follow-up. Operative neurosurgery, 13(4), 492-502. Doi:10. 1093/ons/opx032 the pipeline devices have not been returned for evaluation; product analysis cannot be performed. The devices were not returned; the reported events could not be confirmed. The cause of the events could not be conclusively determined from the provided information. Mdrs related to this article: 2029214-2018-00292, 2029214-2018-00293. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic literature review found reports of pipeline (ped) intraoperative deployment complications. The purpose of this article was to evaluate the risk of complications after flow diverter (fd) treatment vs. Fd + coil treatment of large/giant internal carotid artery (ica) aneurysms. The authors reviewed 44 patients with large or giant ica aneurysms: 26 patients underwent treatment using fd alone and 18 patients underwent treatment using fd + coils. Of the 44 patients, 12 were male and 32 were female; mean age was 58. 3 years. The article states that deployment complications included accidental iatrogenic fd migration, intra-aneurysmal fd migration, distal fd misplacement, and simple deployment difficulties without relevant repercussion. The article states that deployment complications occurred in the following cases without specifying what type of deployment complication occurred. In case 9, the patient ((b)(6), male) underwent placement of a ped as well as two fds from another manufacturer in the treatment of a large, saccular intracavernous aneurysm (15mm). The patient experienced intraoperative fd deploy complication; the article does not specify which fd was involved. The patient's mrs was 0 post-operatively as well as one year post-operatively. In case 41, the patient ((b)(6), female) underwent placement of two peds in the treatment of a large, saccular supraclinoid aneurysm (18mm). The patient experienced intraoperative fd deploy complication. As of one year post-procedure, the patient's mrs was 0.
 
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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 Key7441617
MDR Text Key105920342
Report Number2029214-2018-00293
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 04/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received03/26/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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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