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

Model Number FA-71500-30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 04/29/2016

Event Type  Injury  

Manufacturer Narrative

Wendl, c.M., henkes, h., moreno, r.M., ganslandt, o., bäzner, h., <(>&<)> pérez, m.A.(2016).Direct carotid cavernous sinus fistulae: vessel reconstruction using flow-diverting implants.Clinical neuroradiology, 27(4), 493-501.Http://doi.Org/10.1007/s00062-016-0511-6 the pipeline device will not be returned for evaluation as it was implanted in the patient.Based on the provided information, there does not appear to have been any defect of the pipeline device during use.The incomplete diccf occlusion occurred in the patient post-procedure and its cause could not be conclusively determined from the reported information.It should be noted that the pipeline indications for use states, "the ped is intended for endovascular embolization of cerebral aneurysms." mdrs related to this article: 2029214-2018-00185 2029214-2018-00186 2029214-2018-00187 2029214-2018-00188 2029214-2018-00189 2029214-2018-00190 2029214-2018-00191 2029214-2018-00192 2029214-2018-00193.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic literature review found report that a patient underwent retreatment after pipeline implantation.The purpose of this article was to evaluate the experience of using flow diverters (fd) for endovascular treatment of direct carotid-cavernous sinus fistulae (diccf).The authors retrospectively reviewed 14 patients (3 male, 11 female, median age 59 years) with 14 diccf who underwent treatment with fd alone, fd in combination with coils, or covered stents.The article states that fd placement was technically successful in all patients.In addition, the article states that there were no adverse events related to fd placement in any patient.Patient 9 (female, (b)(6)) presented with spontaneous diccf and was initially treated using coils.Two days after initial treatment, follow-up imaging showed incomplete diccf occlusion.The patient underwent a second treatment session that day in which eight pipeline devices were placed.26 days after initial treatment, follow-up imaging again showed incomplete diccf occlusion and the patient underwent another retreatment session in which additional coils were placed.As of 521 days after the initial treatment, follow-up imaging showed the diccf was completely occluded.The patient's mrs was noted to be 0.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL 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 Key: 7333000
• MDR Text Key: 102182456
• Report Number: 2029214-2018-00193
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FA-71500-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR