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	H7493926032220
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.A 2.25 x 32 synergy ii drug eluting stent was selected for use.However, during preparation, it was noted that the stent was dislodged from the balloon.The procedure was completed with a 2.25x32mm synergy ii drug-eluting stent.No patient complication were reported.
Additional Manufacturer Narrative
Device evaluated by mfr:the stent delivery catheter (sds) was returned for analysis.A visual examination of the crimped stent found that the stent had detached from the delivery system, the stent was damaged along its entire length with stent struts stretched, squashed close together and distorted.The maximum crimped stent profile is within the specification.The stent protector inner diameter of the returned device was measured using pin gauge and is within the specified inside diameter of the stent protector specification.It can be determined that the stent protector was not too tight on the crimped stent provided the correct removal of the stent protector was used.Based on the specified stent protector profile and the recorded crimped stent profile, there is no issues to note with the interaction between the two components.The balloon body was reviewed and no issues were noted with the overall balloon.Crimp markings were visible on the exposed balloon wall.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.The bumper tip of the device showed no signs of damage.A visual and tactile examination found multiple kinks across the length of the hypo tube shaft.A visual and tactile examination of the outer and mid-shaft section found a mid-shaft kink 140mm proximal from the port site entry.The bi-component bond showed no signs of damage or strain.These types of damage are consistent with excessive force being applied to the delivery system.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.A 2.25 x 32 synergy ii drug eluting stent was selected for use.However, during preparation, it was noted that the stent was dislodged from the balloon.The procedure was completed with a 2.25x32mm synergy ii drug-eluting stent.No patient complication were reported.

• 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: 6096613
• Report Number: 2134265-2016-09940
• Device Sequence Number: 13700438
• Product Code: NIQ
• UDI-Device Identifier: 08714729840329
• UDI-Public: (01)08714729840329(17)20170210(10)18963676
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/10/2017
• Device Model Number: H7493926032220
• Device Catalogue Number: 39260-3222
• Device Lot Number: 18963676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2016
• Supplement Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1