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	H7493926028220
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).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.A 2.25 x 28 synergy ii drug-eluting stent was advanced to treat the lesion.However it was noted that no stent was mounted on the stent delivery system.The stent dislodged prior to entering the patient's body.The device was then removed and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Upn- search corrected from (b)(4) - synergy ii us mr 4.00 x 16 - 39260-1640 to (b)(4) - synergy ii us mr 2.25 x 28 - 39260-2822.Upn corrected (b)(4).Catalog/model # corrected from 39260-1640 to 39260-2822.Device evaluated by mfr: a synergy ii us mr 2.25 x 28mm was returned for analysis; the manifold of the stent delivery system was not returned.An examination of the crimped stent found damage to the proximal region of the stent.Stent strut rows 1-9 from the distal end of the stent were undamaged; the remainder of the struts were damaged and deformed.The proximal struts were damaged and bunched in a distal direction exposing approximately 6mm of the balloon wall.The crimped stent outer diameter of the undamaged distal section was measured and the result was within the maximum crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube found multiple kinks along the full catheter length.There was a break in the hypotube at approximately 134cm from the distal tip of the device.The proximal end of the device containing the manifold was not returned for analysis.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage or strain.The tip was visually examined and no issues were found.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 dislodgment occurred.A 2.25 x 28 synergy ii drug-eluting stent was advanced to treat the lesion.However it was noted that no stent was mounted on the stent delivery system.The stent dislodged prior to entering the patient's body.The device was then removed and the procedure was completed with another of the same device.No patient complications 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: 6534960
• Report Number: 2134265-2017-04235
• Device Sequence Number: 19080641
• Product Code: NIQ
• UDI-Device Identifier: 08714729840268
• UDI-Public: (01)08714729840268(17)20180201(10)20263175
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/12/2017

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: 02/01/2018
• Device Model Number: H7493926028220
• Device Catalogue Number: 39260-2822
• Device Lot Number: 20263175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2017
• Supplement Report FDA Received Date: 06/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1