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

Model Number	10602
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Age at time of event: 18 years or older.
Event or Problem Description
It was reported stent damage occurred which required additional intervention.The 2.50 x 16 synergy drug-eluting stent was successfully implanted in the proximal left anterior descending (lad) artery.The guidewire was repositioned into the left circumflex (lcx) artery and a second unknown stent was advanced but was unable to cross the lesion.When the unknown stent was removed from the lcx, it hung up on the previously placed stent in the lad which stretched and was partially in the left main artery.It was noted the synergy stent was place to close to the left main and there is a possibility that when repositioning the guidewire, it went through one of the synergy stent struts and when the unknown stent was being removed it got hung up and damaged the synergy stent.The patient underwent bypass surgery which was successful and the patient status was stable.

• 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: 8121132
• Report Number: 2134265-2018-63109
• Device Sequence Number: 1656889
• Product Code: NIQ
• UDI-Device Identifier: 08714729840091
• UDI-Public: 08714729840091
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2018

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: 04/09/2019
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0022038798
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 11/30/2018
• 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