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

Model Number UNKNOWN

Device Problem Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2018

Event Type  malfunction  

Manufacturer Narrative

Citation: morphologic feature elongation can predict occlusion status following pipeline embolization of intracranial aneurysms.Yupeng zhang1, chao ma1, shikai liang2 et al.Journal world neurosurgery 2018) 119:e934-e940.The median age of patients was 54.0 years old (iqr: 49.3e58.8 years), and 75.9% of patients were female.The pipeline device will not be returned for investigation as it was implanted in the patient; therefore, no definitive conclusion can be drawn regarding the clinical observation.Per our instructions for use (ifu): "begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex has successfully expanded, deploy the remainder of the device.Carefully inspect the deployed pipeline flex embolization device under fluoroscopy to confirm that it is completely apposed to the vessel wall and not kinked.If the device is not fully apposed or is kinked, consider using a balloon catheter, micro catheter, or guide-wire to fully open it." if information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information through literature reviewed that balloon angioplasty was used to expand the stent in case of incomplete opening of the ped.However, mal apposition of the ped still occurred in 12.1% of all procedures.Adjunctive coiling was performed in 50.0% of aneurysms (29 of 58), and the packing density was relatively loose.Only 1 ped was used in 89.7% of aneurysms, and the remaining aneurysms were treated with 2 telescoped flow diverters.From january 2016 to september 2017, 58 patients with 58 aneurysms were treated with the pipeline embolization device.All aneurysms included were unruptured, and 89.7% were located in the anterior circulation.Of aneurysms, 41.4% were small (maximum diameter <(><<)>10 mm), 43.1% were large (diameter 10e24 mm), and 15.5% were giant (diameter _25 mm).

• Brand Name: PIPELINE FLEX 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 ; 9498373700
• MDR Report Key: 8151624
• MDR Text Key: 130641279
• Report Number: 2029214-2018-01052
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2018
• 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