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	H7493926038220
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is combination product.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
Same case as mdr# 2134265-2017-13232.It was reported that stent dislodgment and device fracture occurred.The target lesions were located in the left anterior descending (lad) and left circumflex (lcx) arteries.A 2.25x38 stent was implanted in the distal lad and a 2.25x24 synergy stent was implanted in the proximal to ostial lad.A 2.25x38 synergy stent was introduced but the stent was dislodged from the balloon while attempting to cross the distal lcx.The dislodged stent was removed with a snare.The physicians noticed something that looked like a wire in the lad.The access part of the stent was able to be retrieved.The lad was then re-engaged and it was noted that the 2.25x24 synergy stent previously implanted in the proxima to ostial lad had moved from its original position and was deformed the physician could not cross this deformed stent with a wire and the patient was sent for bypass.Following bypass the patient was stable.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Previously it was reported that stent dislodgment and shaft facture of the 2.25x38mm synergy stent occurred.Now it is reported that only stent dislodgment occurred.Previously it was reported that stent deformation of the 2.25x24mm synergy stent occurred.Now it is reported that stent fracture occurred.It was further reported that the 2.25x38mm synergy stent interacted with the 2.5x24mm synergy stent and pulled that stent out of the lad.Half the 2.25x24mm synergy stent was fractured and explanted.

• 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: 7183167
• Report Number: 2134265-2017-13231
• Device Sequence Number: 16183997
• Product Code: NIQ
• UDI-Device Identifier: 08714729840381
• UDI-Public: 08714729840381
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/18/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2018
• Device Model Number: H7493926038220
• Device Catalogue Number: 39260-3822
• Device Lot Number: 20771026
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 02/15/2018
• 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
• Patient Age: 62 YR