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	H7493926008300
Medical Device Problem Codes	Bent (1059); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is combination product.(b)(4).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
Same case as mdr id: 2134265-2016-10081.It was reported that stent moved on balloon and stent damage occurred.The target lesion was located in a very calcified right coronary artery (rca).A 3.00x8mm synergy ii everolimus-eluting platinum chromium coronary stent system was advanced to treat the lesion.However, during the procedure, the stent could have moved on the balloon and the physician noticed that the stent had a longitudinal depression so the physician deployed the stent in proximal rca.Because of the crunching of the first stent, the physician advanced a 3.00x12mm synergy ii everolimus-eluting platinum chromium coronary stent system and the stent could also have moved on the balloon and also had some longitudinal depression so the physician deployed the second stent as well in proximal rca.Both stents were post dilated.The procedure was completed with a non-bsc stent implanted in the ostium of the lesion.No patient complications were reported and the patient's status was stable and fine.

• 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: 6106803
• Report Number: 2134265-2016-10080
• Device Sequence Number: 839030
• Product Code: NIQ
• UDI-Device Identifier: 08714729839996
• UDI-Public: (01)08714729839996(17)20170615(10)19425181
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2016

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: 06/15/2017
• Device Model Number: H7493926008300
• Device Catalogue Number: 39260-0830
• Device Lot Number: 19425181
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2016
• Initial Report FDA Received Date: 11/16/2016
• 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