MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2020-02-07 for NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITH TIP M003ETAS30210 manufactured by Stryker Neurovascular Cork.
[178380876]
Subject device remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[178380877]
It was reported that during aneurysm stenting procedure with the subject stent, the patient experienced a transitory complication with thrombus at the neck, responsible of slowing flow in right anterior cerebral artery. There was resolution of the thrombus with a bolus of reopro in situ and hemodynamical optimization. After procedure, the patient showed an isolate event of right arm dyspraxia, spontaneously resolved with no recurrence in less that 24 hours from procedure. The physician confirmed that the neck thrombus was related to both subject stent and procedure. The physician also confirmed that the right arm dyspraxia was a consequence of the thrombus. Patient medical history includes hypertension, current smoker, previous hemorrhagic stroke ((b)(6) 2017), previous treatment of non-target aneurysm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008881809-2020-00036 |
| MDR Report Key | 9684282 |
| Report Source | STUDY |
| Date Received | 2020-02-07 |
| Date of Report | 2020-03-11 |
| Date of Event | 2017-06-10 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2017-02-15 |
| Date Added to Maude | 2020-02-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TARA LOPEZ |
| Manufacturer Street | 47900 BAYSIDE PARKWAY |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 5104132500 |
| Manufacturer G1 | STRYKER NEUROVASCULAR CORK |
| Manufacturer Street | IDA INDUSTRIAL ESTATE MODEL FARM ROAD |
| Manufacturer City | CORK NA |
| Manufacturer Country | IE |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITH TIP |
| Generic Name | STENT, INTRACRANIAL NEUROVASCULAR |
| Product Code | NJE |
| Date Received | 2020-02-07 |
| Catalog Number | M003ETAS30210 |
| Lot Number | 19611386 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER NEUROVASCULAR CORK |
| Manufacturer Address | IDA INDUSTRIAL ESTATE MODEL FARM ROAD CORK NA IE NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-02-07 |