MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 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	Prolapse (2475)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of birth: (b)(6).Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that tissue prolapse occurred.The target lesion was located in the right coronary artery.A 2.75 x 16 synergy ii everolimus-eluting platinum chromium coronary stent system was advanced and successfully deployed.Following implantation, tissue prolapse was noted.A 2.75x8mm synergy stent was selected to resolve the issue.No further patient complications were reported.

• 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 - GALWAY
• MDR Report Key: 6516564
• Report Number: 2134265-2017-04173
• Device Sequence Number: 11172978
• Product Code: NIQ
• UDI-Device Identifier: 08714729840107
• UDI-Public: (01)08714729840107(17)20170509(10)19270636
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2017

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: 05/09/2017
• Device Model Number: H7493926016270
• Device Catalogue Number: 39260-1627
• Device Lot Number: 19270636
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 04/24/2017
• 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
• Patient Age: 55 YR