MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 3.0MM X 25MM - IDE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number M003102USHP0

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

Patient Problems Stroke/CVA (1770); Ischemia Stroke (4418)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

The subject device remained inside patient.

Event Description

It was reported that the patient was treated with the subject flow diverting stent on (b)(6) 2015.The patient was admitted to the hospital on (b)(6) 2020 for serious adverse event of ischemic stroke (left sided weakness/numbness, severe in intensity), serious as it led to the deterioration in the health of the subject that resulted in in-patient hospitalization.They were previously diagnosed with colon cancer which has now developed into advanced metastatic cancer.The med list did not indicate that they were taking asa (acetylsalicylic acid).However, for their 4yr follow-up visit on (b)(6) 2019, they had mentioned that their cancer doctor had told them to stop taking their asa.After discussing with doctor at the time, the subject was told to restart the asa, which they agreed to do.Ir angiography revealed that the specific to the right hemispheric stroke, a relative radiolucency just distal to the rica, subject flow diverting stent was identified.The finding could be consistent with a small non-occlusive platelet aggregate.There is no concern for flow limitation.The vessel is widely patent and there is no in-stent stenosis.No other abnormality involves the rica circulation.The patient was discharged on (b)(6) 2020 to a rehabilitation facility in stable condition.Medications at discharge included asa 81 mg indefinitely and plavix 75mg for three weeks.She was brought to the er emergency room) from ipr with altered mentation following a fall and readmitted (b)(6) 2020.According to emr chart review she was on dual anti-platelet therapy (asa/plavix), excedrin and prophylactic lovenox.Per the family, the patient experienced an unwitnessed fall at the rehab center 12 hours earlier in the day, they were notified by phone.The patient told her family that she did not knock her head and that she landed on her bottom.She was found to have a subdural hematoma with uncal herniation, gsc of 3, comatose.On examination, right pupil not responsive, left pupil poorly visualized.Neurologic: nonresponsive, no responses to command, no myoclonus, no tremor on (b)(6) 2020 (1820 days post procedure) the patient expired.Based on the response from the site that the device did not malfunction her death was due to traumatic intracranial hemorrhage.The patient suffered a sub-dural hematoma with uncal herniation after a fall in rehab.Because she was on palliative care, as her cancer was terminal, she was a dnr (do-not-resuscitate).

Event Description

It was reported that the patient was treated with the subject flow diverting stent on (b)(6) 2015.The patient was admitted to the hospital on (b)(6) 2020 for serious adverse event of ischemic stroke (left sided weakness/numbness, severe in intensity), serious as it led to the deterioration in the health of the subject that resulted in in-patient hospitalization.They were previously diagnosed with colon cancer which has now developed into advanced metastatic cancer.The med list did not indicate that they were taking asa (acetylsalicylic acid).However, for their 4yr follow-up visit on (b)(6) 2019, they had mentioned that their cancer doctor had told them to stop taking their asa.After discussing with doctor at the time, the subject was told to restart the asa, which they agreed to do.Ir angiography revealed that the specific to the right hemispheric stroke, a relative radiolucency just distal to the rica, subject flow diverting stent was identified.The finding could be consistent with a small non-occlusive platelet aggregate.There is no concern for flow limitation.The vessel is widely patent and there is no in-stent stenosis.No other abnormality involves the rica circulation.The patient was discharged on (b)(6) 2020 to a rehabilitation facility in stable condition.Medications at discharge included asa 81 mg indefinitely and plavix 75mg for three weeks.She was brought to the er emergency room) from ipr with altered mentation following a fall and readmitted (b)(6) 2020.According to emr chart review she was on dual anti-platelet therapy (asa/plavix), excedrin and prophylactic lovenox.Per the family, the patient experienced an unwitnessed fall at the rehab center 12 hours earlier in the day, they were notified by phone.The patient told her family that she did not knock her head and that she landed on her bottom.She was found to have a subdural hematoma with uncal herniation, gsc of 3, comatose.On examination, right pupil not responsive, left pupil poorly visualized.Neurologic: nonresponsive, no responses to command, no myoclonus, no tremor.On (b)(6) 2020 (1820 days post procedure) the patient expired.Based on the response from the site that the device did not malfunction her death was due to traumatic intracranial hemorrhage.The patient suffered a sub-dural hematoma with uncal herniation after a fall in rehab.Because she was on palliative care, as her cancer was terminal, she was a dnr (do-not-resuscitate).

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The event description indicates the patient suffered a sub-dural hematoma with uncal herniation after a fall in rehab.Because she was on palliative care, as her cancer was terminal, she was a dnr.The device did not malfunction her death was due to traumatic intracranial hemorrhage.An assignable cause of anticipated procedural complication will be assigned to the reported event as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.

• Brand Name: SURPASS STREAMLINE 3.0MM X 25MM - IDE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10409462
• MDR Text Key: 203144311
• Report Number: 3008881809-2020-00239
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2016
• Device Catalogue Number: M003102USHP0
• Device Lot Number: 18286480
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 58 YR