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	H7493926008220
Medical Device Problem Code	Malposition of Device (2616)
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
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 stent dislodgment occurred.The target lesion was located in the distal right coronary artery (rca).A 2.25 x 8mm synergy ii drug-eluting stent was advanced through a previously implanted stent.However, it was noted that the stent came off the balloon.Another balloon catheter was advanced into the proximal rca and deployed the dislodged stent.The procedure was then completed.No further patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: a synergy ii us mr 2.25 x 8mm stent delivery system (sds) was returned for analysis.The stent was not returned with the sds for analysis.The manufacturing crimp data for this device was reviewed and there were no issues to note.The maximum stent profile measurement which is within max crimped stent profile measurement.The balloon body was reviewed and there were no issues to note.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.There were crimp markings evident on the entire length of the balloon wall indicating overall crimp contact between the balloon and the stent at the time of manufacture.A visual and tactile examination of the device found no issues with the hypotube.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage.The tip was visually and microscopically examined and no issues were noted.No other issues were identified during the product analysis.The most probable cause of the reported difficulties may be due interaction with another device.(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in the distal right coronary artery (rca).A 2.25 x 8mm synergy ii drug-eluting stent was advanced through a previously implanted stent.However, it was noted that the stent came off the balloon.Another balloon catheter was advanced into the proximal rca and deployed the dislodged stent.The procedure was then completed.No further patient complications were reported and the patient's status was 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: 6812837
• Report Number: 2134265-2017-08755
• Device Sequence Number: 16587492
• Product Code: NIQ
• UDI-Device Identifier: 08714729839965
• UDI-Public: (01)08714729839965(17)20170926(10)0019774319
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Health Professional
• Type of Report: Initial,Followup
• 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: 09/26/2017
• Device Model Number: H7493926008220
• Device Catalogue Number: 39260-0822
• Device Lot Number: 0019774319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 10/24/2017
• 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