MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW US 3.00MM X 9MM; CATHETER, BALLOON TYPE

Catalog Number M0032072209300

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

Patient Problems Death (1802); Coma (2417)

Event Date 01/24/2017

Event Type  Death  

Manufacturer Narrative

This is the 5th of 5 reports.H3 other text : subject device is not available.

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 a first 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 with a second balloon catheter (subject device).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 with the second balloon 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

Reportability rationale correction: based on the additional information received, it is confirmed that the second gateway was not responsible for any adverse event, however the device was used to perform the additional angioplasty to treat the vessel dissection.In the physician¿s opinion, the patient¿s outcome was poor without the medical intervention with the possibility of death.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.Initially ¿coma¿ and ¿death¿ were assigned to the second gateway balloon (mfr report # 0002134265-2017-30003).However, since there was no allegation of adverse event against the second gateway balloon, this event does not meet the criteria of a complaint anymore.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

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 a first 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 with a second balloon catheter (subject device).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 with the second balloon 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 US 3.00MM 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: 6354789
• MDR Text Key: 68186509
• Report Number: 0002134265-2017-30003
• Device Sequence Number: 0
• Product Code: PAV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 050001
• 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
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M0032072209300
• Device Lot Number: 17328004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 (STRYKER); 3 WINGSPAN STENTS (STRYKER)
• Patient Outcome(s): Death; Other
• Patient Age: 71 YR