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

Model Number FA-77475-20

Device Problems Delamination (2904); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Seizures (2063)

Event Date 09/23/2016

Event Type  Injury  

Manufacturer Narrative

The pipeline device will not be returned for evaluation as it was implanted in the patient.Based on the reported information, there did not appear to have been any defect of the device during use.The event occurred in the patient post-procedure and its cause could not be conclusively determined from the reported information.

Event Description

Medtronic received report that a patient experienced cerebral edema after pipeline implantation.Patient underwent flow diversion treatment of a blister aneurysm; a pipeline device was implanted.One month post-procedure, angiography showed good results.Two months post-procedure, the patient had focal right convulsive crisis.Cerebral arteriography showed that cortico-subcortico vasogenic edema in left hemisphere, mainly in border zones suggestive of inflammatory process.

Manufacturer Narrative

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.

Manufacturer Narrative

Additional information the pipeline device performed as intended as indicated by successful implantation in the treatment of a blister aneurysm.There were no reports of device issues during the implantation procedure.The pipeline will not be returned for evaluation as it remains implanted in the patient.Product analysis cannot be performed.It was reported that two months post-procedure, the patient experienced a focal right convulsive crisis.Cerebral arteriography showed edema in the left hemisphere.The patient received corticoid therapy with dexamethasone and anticonvulsant.The patient is currently asymptomatic with improvement in image examination, presenting only signs of contrast uptake and edema reduction.An independent medical review was sought to investigate the customer¿s allegation of ptfe relationship to the event.Review of the provided images (select angiographic, mr, and ct images) could not confirm the customer¿s allegation of pipeline ptfe embolization.Because the patient presented with clinical symptoms approximately two months after pipeline implantation, ptfe embolization would be an unlikely culprit for the adverse event.Only the core wire of the pipeline delivery system contains ptfe; the implantable portion of the pipeline device does not contain any ptfe.If ptfe delamination were the cause of the post-procedure symptoms, the ptfe would have most likely been released at the time of pipeline implantation; it would seem unlikely to then cause no symptoms for several months.It should be noted that this clinical scenario (delayed symptoms) has been reported in other cases and has presumed to be due to embolization of hydrophilic polymer fragments from catheters¿ polyvinyl propylene.The provided images are inconclusive regarding a potential relationship between the vasogenic edema and possible embolization of ptfe.A relationship between possible ptfe embolization and the patient¿s delayed hypersensitivity reaction cannot be confirmed; in addition, contribution of ptfe cannot be ruled out given the information available.

Manufacturer Narrative

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

• 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: 6140207
• MDR Text Key: 61289910
• Report Number: 2029214-2016-01083
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/05/2016

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
• Device Expiration Date: 11/16/2017
• Device Model Number: FA-77475-20
• Device Lot Number: A018470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 05/08/2017
• Supplement Dates FDA Received: 12/16/2016; 05/24/2017; 05/25/2017; 09/27/2017
• Date Device Manufactured: 11/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2029214-10/7/16-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR