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	H7493926016270
Medical Device Problem Codes	Bent (1059); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent dislodgement and stent damage occurred.The target lesion was located in the left circumflex (lcx) artery.A 2.75 x 16 synergy ii drug eluting stent was advanced to treat the lesion.However before deployment, the stent came off the balloon and the proximal end accordioned inside the body.The physician was able to deliver a small size balloon and inflated the stent, and also placed a non-compliant balloon to dilate the stent once.A promus stent was then deployed over the synergy stent.No further patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Stent delivery system (sds) was returned for analysis.The stent had detached from the delivery system and was not returned for analysis.The tip was visually and microscopically examined and no issues were noted.The balloon body was reviewed and no issues were noted with the overall balloon.It appeared as if positive pressure was applied and a vacuum pulled as balloon wings were out of their folded position.A visual and tactile examination found multiple kinks along the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the outer and mid-shaft section found no issues with the shaft polymer extrusion.The bi-component bond showed no signs of damage or strain.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 operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that stent dislodgement and stent damage occurred.The target lesion was located in the left circumflex (lcx) artery.A 2.75 x 16 synergy ii drug eluting stent was advanced to treat the lesion.However before deployment, the stent came off the balloon and the proximal end accordioned inside the body.The physician was able to deliver a small size balloon and inflated the stent, and also placed a non-compliant balloon to dilate the stent once.A promus stent was then deployed over the synergy stent.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: 6334696
• Report Number: 2134265-2017-01121
• Device Sequence Number: 1016587
• Product Code: NIQ
• UDI-Device Identifier: 08714729840107
• UDI-Public: (01)08714729840107(17)20170920(10)19761511
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/30/2017

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: 09/20/2017
• Device Model Number: H7493926016270
• Device Catalogue Number: 39260-1627
• Device Lot Number: 19761511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2017
• Supplement Report FDA Received Date: 03/17/2017
• 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