MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-04-08 for UNKNOWN_NEUROVASCULAR_PRODUCT UNK_NEU manufactured by Boston Scientific - Minn.
[42235942]
The exact date of the adverse event is unknown. All patients were treated between (b)(6) 2013 and (b)(6) 2015. This report is 2 of 2 covering balloon treated patients that experienced strokes, transient ischemic attacks and death. The subject device is not available.
Patient Sequence No: 1, Text Type: N, H10
[42235943]
The stroke journal documented the results of a thirty-day outcome of a multicenter registry study of stenting for symptomatic intracranial artery stenosis. The article informed that 141 patients were treated with the balloon (subject device) pre-dilation plus self-expanding stenting. Of the patients treated, 6 patients had a 30 days primary end points of stroke, transient ischemic attack, and death. In addition, 6 patients had secondary end points of unsuccessful revascularization. It was not possible to ascertain specific device or patient information from the article, or to match the events reported with previously reported complaints. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[47896765]
A review of the device history record could not be performed because the lot number was not reported. The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed. However, transient ischemic attack(tia), stroke and death are known risks associated with endovascular procedures and are listed as such in the device directions for use (dfu). Therefore, an assignable cause of anticipated procedural complications was assigned to this event.
Patient Sequence No: 1, Text Type: N, H10
[47896766]
The stroke journal documented the results of a thirty-day outcome of a multicenter registry study of stenting for symptomatic intracranial artery stenosis. The article informed that 141 patients were treated with the balloon (subject device) pre-dilation plus self-expanding stenting. Of the patients treated, 6 patients had a 30 days primary end points of stroke, transient ischemic attack, and death. In addition, 6 patients had secondary end points of unsuccessful revascularization. It was not possible to ascertain specific device or patient information from the article, or to match the events reported with previously reported complaints. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008853977-2016-00128 |
| MDR Report Key | 5564667 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-04-08 |
| Date of Report | 2016-03-11 |
| Date of Event | 2013-09-01 |
| Date Mfgr Received | 2016-05-25 |
| Date Added to Maude | 2016-04-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. SANDA DRACIC |
| Manufacturer Street | 47900 BAYSIDE PARKWAY |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 5104132500 |
| Manufacturer G1 | BOSTON SCIENTIFIC - MINN |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN_NEUROVASCULAR_PRODUCT |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | PAV |
| Date Received | 2016-04-08 |
| Catalog Number | UNK_NEU |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MINN |
| Manufacturer Address | ONE SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2016-04-08 |