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

Model Number FA-77400-20

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

Patient Problems Neurological Deficit/Dysfunction (1982); Thromboembolism (2654)

Event Type  Injury  

Manufacturer Narrative

The device was not retuned for analysis as it was implanted in the patient.Attempts have been made to obtain additional information, however, our attempts have been unsuccessful.The flow diverter was reported to have performed as intended by successful deployed and implantation within the intended treating location.Therefore, there is no allegation that the device was defective or that a malfunction occurred during its use.This event appears to be more patient condition and procedure related.However, its exact cause is unknown.Thromboembolism is a known inherent risk of endovascular procedure and is documented in our device's instruction for use.Linked mdrs events: 2029214-2017-00881 and 2029214-2017-00882.

Event Description

Citation: "antiplatelet drug resistance did not increase the thromboembolic events after stent-assisted coiling of unruptured intracranial aneurysm: a single center experience of 99 cases".Jihye song, yong sam shin.Neurol sci (2017) 38:879-885 doi 10.1007/s10072-017-2859-z.Medtronic received the following reports: a (b)(6) female patient was treated with one flow diverter 4-20, for a right ophthalmic aneurysm.The patient was reported to have an acute thromboembolic event.The patient symptoms were left side weakness, facial palsy.The patient was conservatively managed and was not on any antiplatelet medication.At one month follow up, the mrs was 1.

• Brand Name: PIPELINE
• 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 ; 9492753836
• MDR Report Key: 6701867
• MDR Text Key: 79645962
• Report Number: 2029214-2017-00880
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FA-77400-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Disability
• Patient Age: 50 YR