MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-13 for SURPASS 5X50 M003123FPP0 manufactured by Stryker Neurovascular Cork.
[138756264]
This is 1 of the 2 reports for this event. The device remains in patient.
Patient Sequence No: 1, Text Type: N, H10
[138756265]
It was reported that approximately 16 months after the procedure for the aneurysm at the right internal carotid, digital subtraction angiography (dsa) showed a non-optimal position of the fusiform aneurysm component of the internal carotid artery (ica) after dissection, provided by the flow diverter. Then approximately 2 months later, a percutaneous transluminal angioplasty (pta) of the flow diverter was performed several times to treat the dissection aneurysm. Good dilation result showed in the proximal flow diverter section, however no relevant enhancement in the distal end. Approximately 2 years after the initial procedure, dsa showed the depletion of the proximal lumen of the flow diverter increased again compared to right after the pta. And the flow diverter tapered lute-like towards the proximal end. The remaining partly incomplete wall adaption of the flow diverter with sufficient lumen and flow was not changed, not progressive. Intracranial perfusion also appeared unchanged and unaffected. In the physician? S opinion, the event was related to the implanted flow diverter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008881809-2019-00073 |
| MDR Report Key | 8419114 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-13 |
| Date of Report | 2019-04-17 |
| Date of Event | 2018-04-11 |
| Date Mfgr Received | 2019-04-17 |
| Date Added to Maude | 2019-03-13 |
| 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 Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURPASS 5X50 |
| Generic Name | INTRACRANIAL ANEURYSM FLOW DIVERTER |
| Product Code | OUT |
| Date Received | 2019-03-13 |
| Catalog Number | M003123FPP0 |
| Lot Number | 18849692 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | STRYKER NEUROVASCULAR CORK |
| Manufacturer Address | IDA INDUSTRIAL ESTATE MODEL FARM ROAD CORK NA NA |
| Brand Name | SURPASS 5X50 |
| Generic Name | INTRACRANIAL ANEURYSM FLOW DIVERTER |
| Product Code | NVI |
| Date Received | 2019-03-13 |
| Catalog Number | M003123FPP0 |
| Lot Number | 18849692 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-03-13 |