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

Model Number	10606
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that balloon rupture occurred and removal difficulties were encountered.The target lesion was located in the heavily calcified left anterior descending artery.A 2.25 x 32mm synergy stent was advanced for treatment.However, during deployment, the stent delivery system (sds) balloon ruptured.When trying to remove the sds, the physician was unable to push it forward or pull it into the guide catheter.In order to dislodge the sds, the hub was cut off and a 5fr guideliner extension catheter was placed over the wire and stuck sds.The stent balloon was completely removed and the stent was left in place with no harm to the patient or implanted stent.

• 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: 8651964
• Report Number: 2134265-2019-05771
• Device Sequence Number: 13548327
• Product Code: NIQ
• UDI-Device Identifier: 08714729840329
• UDI-Public: 08714729840329
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2019

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: 02/13/2021
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0023389220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 05/29/2019
• 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