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	H7493926032350
Medical Device Problem Codes	Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, 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 the stent was explanted.The two target lesions were located in the diagonal and left anterior descending (lad) artery.A 3.50x32mm synergy ii drug-eluting stent was initially placed in the diagonal.A 2.75x16mm synergy stent was advanced but the device was unable to cross the lesion.The device was removed and replaced with a 2.5x23mm non-bsc stent; however the device was unable to fully cross the lesion.Upon removal of the non-bsc stent, it became entangled with the implanted synergy stent and was explanted.Both, the non-bsc and synergy stents were snared out from the patient's body.The procedure was completed with placement of 3.5x24mm and 2.5x24mm synergy stents in the lad and diagonal.The following day, the patient was discharged.No patient complications were reported and the patient's status 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: 6421712
• Report Number: 2134265-2017-02190
• Device Sequence Number: 16275819
• Product Code: NIQ
• UDI-Device Identifier: 08714729840367
• UDI-Public: (01)08714729840367(17)20170808(10)19596021
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2017

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: 08/08/2017
• Device Model Number: H7493926032350
• Device Catalogue Number: 39260-3235
• Device Lot Number: 19596021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2017
• Initial Report FDA Received Date: 03/21/2017
• 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