MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	H7493926016270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: the complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2018-01765, 2134265-2018-01766, 2134265-2018-01767, 2134265-2018-01777 and 2134265-2018-01778.It was reported that decreased blood flow occurred.In (b)(6) 2017, the patient presented with st elevation myocardial infarction (stemii).A 2.25 x 28 mm synergy stent and a 2.5016 synergy stent were implanted in the distal right coronary artery (rca).In (b)(6) 2018, the patient presented with an 85-99% stenosed mid rca and a 90% restenosed distal rca.No calcification was noted.A 185 cm str pt²¿ guide wire was introduced.The mid rca was treated with two synergy ii drug-eluting stents, a 2.75 x 16 mm and a 2.75 x 24 mm.The distal rca was treated with a 2.50 x 12 mm synergy ii drug-eluting stent.A 3.0 x 20 mm nc quantum balloon catheter was used for post dilatation.When the physician pulled the pt²¿ guide wire back, the wire caught behind a stent strut and approximately 10 mm of the tip broke off in the distal rca stent.The physician attempted to rewire the vessel so the detached tip could be covered with a stent, but the physician was unable to advance an emerge balloon catheter to the area and the rca began to have a decreased flow.The patient was transferred by an ambulance to another hospital for a cardiac surgeon to evaluate the possibility of performing surgery to remove the detached tip.The detached tip was not removed and was left inside the patient's body.Two saphenous vein grafts (svg) were performed to the rca and the procedure was completed.No further patient complications were reported and the patient's status was stable.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7339487
• Report Number: 2134265-2018-01776
• Device Sequence Number: 16434223
• Product Code: NIQ
• UDI-Device Identifier: 08714729840107
• UDI-Public: 08714729840107
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2018

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: 11/20/2018
• Device Model Number: H7493926016270
• Device Catalogue Number: 39260-1627
• Device Lot Number: 21448269
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 03/14/2018
• 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: Required Intervention