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	H7493926008400
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a 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
It was reported that stent dislodgement occurred.There were two target lesion.They were located in an anomalous circumflex artery and in the ostial right coronary artery (rca).Angioplasty was performed and a stent was implanted in the proximal circumflex artery.However, a dissection was noticed that propagated back to the ostial rca.To treat the dissection, a 4.00 x 8 synergy ii drug-eluting stent was advanced, however, the stent was dislodged and became lodged in the internal iliac artery.The physician determined that the dislodged stent could not be removed and it was left implanted.The ostial rca was then implanted with a 3.5x8 synergy stent.In the circumflex artery, several synergy stents (3.0x12mm, 3.0x8mm and a 4.0x15mm) were successfully implanted.The procedure was then completed.No further patient complications were reported and the patient was doing well during and after the procedure.

• 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: 6806219
• Report Number: 2134265-2017-08505
• Device Sequence Number: 19167222
• Product Code: NIQ
• UDI-Device Identifier: 08714729840015
• UDI-Public: (01)08714729840015(17)20180323(10)0020456304
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2018
• Device Model Number: H7493926008400
• Device Catalogue Number: 39260-0840
• Device Lot Number: 0020456304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 08/18/2017
• 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: 69 YR