MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUNWAY; CATHETER, PERCUTANEOUS

Model Number	8575
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/14/2020
Type of Reportable Event	Death
Event or Problem Description
It was reported via medwatch (b)(4) that death occurred.The patient presented with recent three vein graft heart surgery which had damaged the left anterior descending artery (lad) distal to the attachment of the vein graft.The damage was repaired in the operating room but the artery likely closed the night of the surgery.The patient was noted to be hemodynamically unstable with ventricular tachycardia and with electrocardiogram changes suggestive of a cardiac infarction.The patient was taken emergently to the catherization lab.During the procedure, a model-6f runway cls3.5 guide catheter was in use.The lad distal to the freshly placed graft was occluded;100% stenosed in the middle lad and 70% stenosed in the proximal lad.The physician tried opening the occluded segment with a balloon, but the result was suboptimal, and placement of a stent was then decided as the best option at that time.When the physician placed a 2.25mm stent, the repaired portion of the lad was likely perforated by the graft stitching coming loose.The physician occluded the site with a balloon and decided to place a covered stent as a last resort.The smallest covered stent was 2.5mm but there was no other option than to use the slightly bigger covered stent and try to deploy it at a lower pressure.The 2.5mm stent got hung up in the 2.25mm implanted stent and could not cross to the affected site.During an attempt to remove the 2.5mm stent it likely got stripped off the balloon in the 2.25mm implanted stent.The physician could not get any further devices distal to the 2.25 stent even with multiple balloons.It was further noted that the cause of the patient's death was coronary artery occlusion/cardiac tamponade.

• Brand Name: RUNWAY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10650663
• Report Number: 2134265-2020-13915
• Device Sequence Number: 14353716
• Product Code: DQY
• UDI-Device Identifier: 08714729478386
• UDI-Public: 08714729478386
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K033441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2023
• Device Model Number: 8575
• Device Catalogue Number: 8575
• Device Lot Number: 0060230655
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 75 YR
• Patient Weight: 74