MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10607
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Device is a combination product.
Event or Problem Description
It was reported that stent damage post-deployment occured.The patient presented as a st segment myocardial infarction (stemi) with a complete thrombotic occlusion of the proximal right coronary artery (rca).Vascular access was obtained via the right radial artery.After a 6fr non-bsc guide catheter was inserted and a non-bsc guide wire was delivered to the distal rca, a 2.0 x 12 compliant balloon was delivered and inflated in the vessel which restored timi 2 flow to the rca.Subsequent inflations with a 2.0 x 12 and a 2.5 x 12 unspecified balloon were performed with and further improved timi flow in the rca.A second buddy guide wire, was inserted to the distal vessel and a 2.50 x 38 synergy drug-eluting stent was delivered to the proximal rca which was then deployed at 16 atmospheres.The buddy wire was removed with great difficulty and upon inspection was found to have part of the coating removed from the end of the wire.The next angiogram of the rca revealed that the synergy stent was pulled and elongated into the aorta approximately 15-20mm.The guide wire was removed from the right coronary and access with another guide and guidewire was attempted again but was unsuccessful.A left ventriculogram was performed to visualize the stent within the aortic root.The cardiovascular surgeon was called and the patient was brought to the operating room for removal of the stent from the ostial rca.The stent was removed but the patient was placed in intensive care in guarded condition and will be returned to the operating room for a complete sternotomy closure.
Additional Manufacturer Narrative
Initial reporter fax: (b)(6).Event - updated describe event or problem.Device is a combination product.
Event or Problem Description
It was reported that stent damage post-deployment occured.The patient presented as a st segment myocardial infarction (stemi) with a complete thrombotic occlusion of the proximal right coronary artery (rca).Vascular access was obtained via the right radial artery.After a 6fr non-bsc guide catheter was inserted and a non-bsc guide wire was delivered to the distal rca, a 2.0 x 12 compliant balloon was delivered and inflated in the vessel which restored timi 2 flow to the rca.Subsequent inflations with a 2.0 x 12 and a 2.5 x 12 unspecified balloon were performed with and further improved timi flow in the rca.A second buddy guide wire, was inserted to the distal vessel and a 2.50 x 38 synergy drug-eluting stent was delivered to the proximal rca which was then deployed at 16 atmospheres.The buddy wire was removed with great difficulty and upon inspection was found to have part of the coating removed from the end of the wire.The next angiogram of the rca revealed that the synergy stent was pulled and elongated into the aorta approximately 15-20mm.The guide wire was removed from the right coronary and access with another guide and guidewire was attempted again but was unsuccessful.A left ventriculargram was performed to visualize the stent within the aortic root.The cardiovascular surgeon was called and the patient was brought to the operating room for removal of the stent from the ostial rca.The stent was removed but the patient was placed in intensive care in guarded condition and will be returned to the operating room for a complete sternotomy closure.It was further reported that the patient status was good.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8658321
• Report Number: 2134265-2019-05835
• Device Sequence Number: 16713040
• Product Code: NIQ
• UDI-Device Identifier: 08714729840398
• UDI-Public: 08714729840398
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0023241457
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 05/25/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6FR JR GUIDE CATH; 6FR JR GUIDE CATH; RUNTHROUGH WIRE; RUNTHROUGH WIRE; WHISPER WIRE; WHISPER WIRE; 6FR JR GUIDE CATH; RUNTHROUGH WIRE; WHISPER WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR