MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10605
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodgment occurred.During preparation of a 2.25 x 28 synergy stent, it was noted that the stent came off the balloon.The procedure was completed with another of the same device.No patient complications were reported and the patient status was fine.
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodgment occurred.During preparation of a 2.25 x 28 synergy stent, it was noted that the stent came off the balloon.The procedure was completed with another of the same device.No patient complications were reported and the patient status was fine.Device evaluated by mfr: synergy ii us mr 2.25 x 28mm stent was returned for analysis.The stent delivery system (sds) was not returned for analysis therefore an individual assessment of the catheter could not be performed.The stent was returned separate from the sds which was not returned.The stent was severely damaged and bent.No other issues were identified during the product analysis.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7835143
• Report Number: 2134265-2018-60465
• Device Sequence Number: 1980769
• Product Code: NIQ
• UDI-Device Identifier: 08714729840268
• UDI-Public: 08714729840268
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/15/2018

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: 09/25/2018
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0021186452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1