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

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

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 05/10/2017

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The device was no returned for analysis as the device was implanted. There are various mechanisms underlying late aneurysm recanalization which including the following: growth of the aneurysm itself, instability of fresh, unorganized thrombus and degradation by fibrolysis, continued transmission of blood pulsation affecting the association of the coil-thrombus complex, lack of neointima formation across the neck of aneurysm, formation of neovessels inside the aneurysms lumen, exposing the aneurysm cavity to blood flow. In this case, it is unknown what caused the endo leak. A meta-analysis by murthy et al (2014) showed that 6 months aneurysm occlusion rate after endovascular treatment of intracranial aneurysm with flow diverter is 79. 7%. In this event, the patient was treated successfully treated with another device. Linked event: 2029214-2017-00735, 2029214-2017-00737 and 2029214-2017-00738.

Event Description

Medtronic received report that 2 years post initial treatment with single flow diverter device (4. 25 x 16), there was still filling of the left ica aneurysm, which was not in a bend. An additional device was added to close a distal edge endo leak. The aneurysm was saccular and unruptured with a 10 mm max and 7 mm neck, within the left ica/periophthalmic and was 10 mm. The landing zone was 4. 5 at the distal section and 3. 75 at the proximal. It is unknown where the resistance was coming from, as the anatomy appeared straightforward.

• 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: 6615835
• MDR Text Key: 106975296
• Report Number: 2029214-2017-00736
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

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 Received: 05/10/2017
• 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 Treatment Data

Date Received: 06/06/2017 Patient Sequence Number: 1