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	H7493926020220
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: the complaint device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.Patient presented with st elevation myocardial infarction (stemi).The 100% stenosed target lesion was located in the mid right coronary artery (rca) and a 90% stenosed, 20mm lesion was located in the moderately tortuous and heavily calcified posterior descending artery (pda).A non bsc guide catheter and guidewire were selected and successfully crossed the lesion.The 100% occluded lesion was successfully predilated with a 2.0x12mm non bsc balloon catheter.A 2.0x20mm emerge was used to successfully predilate the pda.A 2.25x28 mm synergy ii was advanced in the pda using a 6f guidezilla ii guide extension catheter but failed to cross the lesion.Another predilation with emerge was made and the synergy was re-advanced but still failed to cross the mid rca lesion.The stent was removed and a 2.25x20mm non bsc balloon catheter was used to predilate the mid rca lesion.Several attempts were made to advance a new 2.25x20 synergy ii stent to the pda through the proximal rca but the stent failed to cross the lesion.The stent delivery system was removed but the stent had dislodged in the rca.An attempt to snare the stent failed.The stent was irretrievable and the patient underwent successful emergent cabg surgery and was stable after surgery.

• 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: 6849691
• Report Number: 2134265-2017-08712
• Device Sequence Number: 13628147
• Product Code: NIQ
• UDI-Device Identifier: 08714729840145
• UDI-Public: (01)08714729840145(17)20170922(10)0019777663
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 08/15/2017

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: 09/22/2017
• Device Model Number: H7493926020220
• Device Catalogue Number: 39260-2022
• Device Lot Number: 0019777663
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/07/2017
• 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: 78 YR