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

Model Number	10604
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent damage occurred.After pre-dilation was performed with a 2.50x15mm emerge balloon catheter , a 2.50 x 24 synergy drug-eluting stent was advanced but failed to cross the lesion.It was also noted that the stent struts were damaged when trying to cross the lesion.No patient complications were reported.Further information has been requested but has not been provided at this time.
Additional Manufacturer Narrative
Device is a combination product.Updated b5: describe event or problem.
Event or Problem Description
It was reported that stent damage occurred.After pre-dilation was perfromed with a 2.50x15mm emerge balloon catheter , a 2.50 x 24 synergy drug-eluting stent was advanced but failed to cross the lesion.It was also noted that the stent struts were damaged when trying to cross the lesion.No patient complications were reported.Further information has been requested but has not been provided at this time.It was further reported that wrong stent size was pulled.Subsequently, an additional stent was advanced and the procedure was completed without consequences.

• 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: 10143976
• Report Number: 2134265-2020-07892
• Device Sequence Number: 19596430
• Product Code: NIQ
• UDI-Device Identifier: 08714729840213
• UDI-Public: 08714729840213
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2020

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: 10/06/2021
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0024590883
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1