MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW JP 2.50MM X 9MM; CATHETER, BALLOON TYPE

Catalog Number M0032072009250

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

Patient Problems Death (1802); Hematoma (1884); Thrombosis (2100); Coma (2417); Vascular Dissection (3160)

Event Date 01/24/2017

Event Type  Death  

Manufacturer Narrative

This is the 3rd of 5 reports.

Event Description

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¿.

Manufacturer Narrative

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.

Event Description

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¿.

Manufacturer Narrative

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.

Event Description

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¿.

• Brand Name: FG GATEWAY OTW JP 2.50MM X 9MM
• Type of Device: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer Contact: michael reddick ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6354692
• MDR Text Key: 68186794
• Report Number: 0002134265-2017-30002
• Device Sequence Number: 1
• Product Code: GBA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: M0032072009250
• Device Lot Number: 19332937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 1 GATEWAY BALLOON CATHETER (STRYKER); 3 WINGSPAN STENTS (STRYKER)
• Patient Outcome(s): Death; Other; Required Intervention
• Patient Age: 71 YR