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

Model Number	10607
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodge occurred.The target lesion was located in the right coronary artery.A 2.75 x 38 synergy ii drug-eluting stent was advanced and placed through previously implanted stent to deliver it distally.However, during the procedure, the stent stripped off of the delivery system and the device was not removed from the patient's body.Inflation was performed and the stent was placed over top of the previous stent.They ended up taking a 6f guidezilla over that wire that was already placed, went through the stent struts of both the previous and new stent and then placed an additional 2.75x38 synergy stent.A guidezilla was used to go through the stents and then placed the other stent distally.The procedure was completed and no patient complications were reported.

• 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: 9703770
• Report Number: 2134265-2020-01263
• Device Sequence Number: 14366125
• Product Code: NIQ
• UDI-Device Identifier: 08714729840404
• UDI-Public: 08714729840404
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

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: 08/18/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0024323453
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/12/2020
• 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