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

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

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

Ryan, r.W., khan, a.S., barco, r., <(>&<)> choulakian, a.(2017).Pipeline flow diversion of ruptured blister aneurysms of the sup raclinoid carotid artery using a single-device strategy.Neurosurgical focus, 42(6).Doi:10.3171/2017.3.Focus1757 the pipeline flex device performed as intended, as indicated by successful implantation in the treatment of a right ica aneurysm.There were no reports of device issues during implantation.The pipeline flex will not be returned for evaluation as it remains implanted in the patient.Product analysis cannot be performed.The information provided is not enough to determine a causal relationship between aneurysm growth and pipeline flex implantation.Based on the reported information, there is no evidence suggesting that the device was defective; this event is more likely to be patient-condition event.Mdrs related to this article: 2029214-2017-00851, 2029214-2017-00852, 2029214-2017-00853.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic literature review found reports of retreatment after pipeline flex implantation.The purpose of this article was to describe the experience with the use of pipeline flow diversion for treatment of ruptured blister aneurysms.The authors identified 13 patients who presented with subarachnoid hemorrhage from ruptured blister aneurysm(s).All patients were treated with pipeline flow diversion.Of the patients, 11 were women and 2 were men.Blister aneurysms were defined as small lesions occurring on the sidewall of the internal carotid artery (ica) at nonbranching sites and having a dome width equal to or great than its height.In case 8, the patient underwent retreatment three months after pipeline flex implantation.The patient had presented with sudden onset of severe headache (hunt and hess grade ii), and a head ct demonstrated diffuse sah (fisher grade 2).The patient underwent diagnostic cerebral angiography, which demonstrated a 3mmx1mm dorsal right ica blister aneurysm, along with a 2.5mmx1mm right posterior communicating artery infundibulum and a 2mmx1mm left posterior communicating artery infundibulum.The ruptured lesion was thought to be the dorsal right ica blister aneurysm given its size and shape.Following angiography the patient was noted to have 3/5 right upper-extremity weakness, and an mri view of the brain showed a small area of acute infarction in the left supplementary motor cortex.Two days later, the patient underwent uncomplicated embolization of the dorsal right ica blister aneurysm with the pipeline flex embolization device.The patient was eventually discharged home in good condition, with improvement in her right upper-extremity weakness to only minimal weakness of her right hand.Three months later, the patient underwent follow-up cerebral angiography, which showed that the treated aneurysm had grown to 4.5mmx2mm, and a second pipeline flex was placed at that time.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (RVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (RVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 6688121
• MDR Text Key: 79120237
• Report Number: 2029214-2017-00852
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 07/05/2017
• 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: 58 YR