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

Model Number PED-475-20

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)

Patient Problems Infarction, Cerebral (1771); Neurological Deficit/Dysfunction (1982); Seizures (2063)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex with shield remains implanted in the patient; product analysis cannot be conducted.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.Suspect medical device brand name: pipeline flex with shield technology model number: ped2-475-20 mdrs related to this event: 2029214-2017-01258, 2029214-2017-01259.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report a pipeline flex with shield device did not open during a flow diversion procedure.The patient was undergoing flow diversion treatment of an unruptured, saccular aneurysm in the left internal carotid artery (ica).The aneurysm hadmax diameter of 9 mm and neck width of 6 mm.The landing zone artery measured 7 mm distally and 9 mm proximally.Vessel tortuosity was described as normal.It was reported the devices were prepared as indicated in the instruction for use.It was reported that during the procedure, the pipeline flex was initially deployed and did not open on the distal end.Upon resheathing, the distal end did open and the procedure could be completed without further issue.The patient did not have any adverse events immediately post-procedure.It was reported that approximately 10 hours post-procedure, the patient experienced neurological problems.Cta and mri were taken and showed small infarctions in the right hemisphere.The vessels and pipeline flex with shield were noted to be open.Six days post-procedure, mri showed a new infarction in the right hemisphere.Clinical observations include paresis of the left arm and recurrent seizures.

• 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 ; 9496801224
• MDR Report Key: 7035940
• MDR Text Key: 93095942
• Report Number: 2029214-2017-01260
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2020
• Device Model Number: PED-475-20
• Device Lot Number: A447316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2017
• Date Device Manufactured: 04/19/2017
• 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 Age: 51 YR