MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-02-23 for FG GATEWAY OTW JP 2.50MM X 9MM M0032072009250 manufactured by Boston Scientific - Minn.
[68186794]
This is the 3rd of 5 reports.
Patient Sequence No: 1, Text Type: N, H10
[68186795]
It was reported that a patient was presented in a life-threatening condition with a basilar thrombotic stroke and neurological deficit. Access to the clot was limited to the right vertebral artery (va) that presented a critical stenosis of the va-distal v4 segment. Left vertebral artery was occluded and not accessible. Angioplasty with the subject balloon catheter of the stenosis of va-v4 segment led to dissection resulting in hematoma and occlusion. Medical intervention in order to restore blood flow through the occluded va- v4 segment by angioplasty was performed without success. Then, stenting of the va-v4 segment with a first stent was performed. However, the distal stent tines did not open properly even with additional angioplasty procedure. Blood flow was not restored. A second stent was attempted to be implanted but could not be deployed beyond the poorly opened distal tines of the first deployed stent. A third stent was deployed more distally in the basilar artery and overlapping the original stent. The stent was only placed with great difficulty through the first stent. There was some bending of the hypotube but it did not render the stent unusable. Blood flow was not restored and injection of platelet aggregation inhibitor into the occluded vessel as well as additional angioplasty was performed. The stent tines and the stents were eventually correctly opened but blood flow was not restored. The physician reported that he would have strongly preferred to use a different size balloon catheter but due to the emergency nature of the procedure, a more appropriately sized balloon was not available. Two days post procedure, the patient was determined to be in "coma" and pronounced dead shortly after. In the physician? S opinion,? The outcome prognosis without the intervention was poor, with death as a possibility. The procedure did not help the patient and may have made him worse. The patient's death is not specifically related to any of the devices?.
Patient Sequence No: 1, Text Type: D, B5
[72811982]
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications. The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed. However, dissection, patient outcome of death, patient hematoma, patient complications, patient thrombosis are known risks associated with endovascular procedures and noted as such in the device directions for use (dfu). Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
Patient Sequence No: 1, Text Type: N, H10
[72811983]
It was reported that a patient was presented in a life-threatening condition with a basilar thrombotic stroke and neurological deficit. Access to the clot was limited to the right vertebral artery (va) that presented a critical stenosis of the va-distal v4 segment. Left vertebral artery was occluded and not accessible. Angioplasty with the subject balloon catheter of the stenosis of va-v4 segment led to dissection resulting in hematoma and occlusion. Medical intervention in order to restore blood flow through the occluded va- v4 segment by angioplasty was performed without success. Then, stenting of the va-v4 segment with a first stent was performed. However, the distal stent tines did not open properly even with additional angioplasty procedure. Blood flow was not restored. A second stent was attempted to be implanted but could not be deployed beyond the poorly opened distal tines of the first deployed stent. A third stent was deployed more distally in the basilar artery and overlapping the original stent. The stent was only placed with great difficulty through the first stent. There was some bending of the hypotube but it did not render the stent unusable. Blood flow was not restored and injection of platelet aggregation inhibitor into the occluded vessel as well as additional angioplasty was performed. The stent tines and the stents were eventually correctly opened but blood flow was not restored. The physician reported that he would have strongly preferred to use a different size balloon catheter but due to the emergency nature of the procedure, a more appropriately sized balloon was not available. Two days post procedure, the patient was determined to be in "coma" and pronounced dead shortly after. In the physician? S opinion,? The outcome prognosis without the intervention was poor, with death as a possibility. The procedure did not help the patient and may have made him worse. The patient's death is not specifically related to any of the devices?.
Patient Sequence No: 1, Text Type: D, B5
[75548466]
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications. The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed. However, dissection, patient outcome of death, patient complications, patient thrombosis are known risks associated with endovascular procedures and noted as such in the device directions for use (dfu). Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
Patient Sequence No: 1, Text Type: N, H10
[75548467]
It was reported that a patient was presented in a life-threatening condition with a basilar thrombotic stroke and neurological deficit. Access to the clot was limited to the right vertebral artery (va) that presented a critical stenosis of the va-distal v4 segment. Left vertebral artery was occluded and not accessible. Angioplasty with the subject balloon catheter of the stenosis of va-v4 segment led to dissection resulting in hematoma and occlusion. Medical intervention in order to restore blood flow through the occluded va- v4 segment by angioplasty was performed without success. Then, stenting of the va-v4 segment with a first stent was performed. However, the distal stent tines did not open properly even with additional angioplasty procedure. Blood flow was not restored. A second stent was attempted to be implanted but could not be deployed beyond the poorly opened distal tines of the first deployed stent. A third stent was deployed more distally in the basilar artery and overlapping the original stent. The stent was only placed with great difficulty through the first stent. There was some bending of the hypotube but it did not render the stent unusable. Blood flow was not restored and injection of platelet aggregation inhibitor into the occluded vessel as well as additional angioplasty was performed. The stent tines and the stents were eventually correctly opened but blood flow was not restored. The physician reported that he would have strongly preferred to use a different size balloon catheter but due to the emergency nature of the procedure, a more appropriately sized balloon was not available. Two days post procedure, the patient was determined to be in "coma" and pronounced dead shortly after. In the physician? S opinion,? The outcome prognosis without the intervention was poor, with death as a possibility. The procedure did not help the patient and may have made him worse. The patient's death is not specifically related to any of the devices?.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002134265-2017-30002 |
| MDR Report Key | 6354692 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-02-23 |
| Date of Report | 2017-05-19 |
| Date of Event | 2017-01-24 |
| Date Mfgr Received | 2017-04-20 |
| Device Manufacturer Date | 2016-06-08 |
| Date Added to Maude | 2017-02-23 |
| 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. MICHAEL REDDICK |
| 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 | FG GATEWAY OTW JP 2.50MM X 9MM |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | PAV |
| Date Received | 2017-02-23 |
| Catalog Number | M0032072009250 |
| Lot Number | 19332937 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |
| Brand Name | FG GATEWAY OTW JP 2.50MM X 9MM |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | GBA |
| Date Received | 2017-02-23 |
| Catalog Number | M0032072009250 |
| Lot Number | 19332937 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| 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 | 1 | 1. Death; 2. Other; 3. Required No Informationntervention | 2017-02-23 |