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

Model Number	10605
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Date of event: unknown.Used the first date of the month of the aware date.
Event or Problem Description
It was reported that stent damage and stent dislodgement occurred.A 4.00 x 28mm synergy ii drug-eluting stent was advanced for treatment.However, the stent got smashed and became stuck in the body.The stent was removed using a snare.No further patient complications were reported and the patient's reported to be okay.
Additional Manufacturer Narrative
Device is a combination product.Date of event: unknown.Used the first date of the month of the aware date.Device evaluated by mfr.: stent delivery system (sds) was not returned for analysis therefore the catheter serial/batch number cannot be identified.A visual examination of the stent found that the stent was severely damaged and deformed the whole length with stent struts stretched.The sds was not returned for analysis therefore reviews for individual assessment of the catheter could not be performed.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage and stent dislodgement occurred.A 4.00 x 28mm synergy ii drug-eluting stent was advanced for treatment.However, the stent got smashed and became stuck in the body.The stent was removed using a snare.No further patient complications were reported and the patient's reported to be okay.

• 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: 8401830
• Report Number: 2134265-2019-02162
• Device Sequence Number: 2029797
• Product Code: NIQ
• UDI-Device Identifier: 08714729840312
• UDI-Public: 08714729840312
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/16/2019

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: 09/23/2020
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 22734901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 04/16/2019
• 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