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	H7493926020270
Medical Device Problem Codes	Device Or Device Fragments Location Unknown (2590); Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr.: the 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 caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesions were located in the left main artery and proximal left anterior descending (lad) artery.A 2.75 x 20 synergy ii drug-eluting stent was advanced to treat the proximal lad lesion but difficulties were encountered in delivering the device.So, the physician treated the left main artery first with a 2.5 x 16 synergy drug-eluting stent.Subsequently, the 2.75 x 20 synergy ii drug-eluting stent was advanced again but the physician still had some difficulties delivering the device.During removal, the physician felt like the stent struts became stuck to the previously implanted stent and after the device was removed from the patient, it was noted that the stent came off the balloon.The stent was nowhere to be found and the physician decided to end the procedure.No further patient complications were reported and the patient's status at the moment 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 - GALWAY
• MDR Report Key: 7331397
• Report Number: 2134265-2018-01670
• Device Sequence Number: 1476741
• Product Code: NIQ
• UDI-Device Identifier: 08714729840169
• UDI-Public: 08714729840169
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/13/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/18/2018
• Device Model Number: H7493926020270
• Device Catalogue Number: 39260-2027
• Device Lot Number: 0021186919
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 03/12/2018
• 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: Other
• Patient Age: 63 YR