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

Model Number	10611
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent damage occurred.A 2.25 x 20 synergy stent was selected for use; however, the stent strut was noted to be broken.The device never entered the patient's body.No patient complications were reported.
Event or Problem Description
It was reported that stent damage occurred.A 2.25 x 20 synergy stent was selected for use; however, the stent strut was noted to be broken.The device never entered the patient's body.No patient complications were reported.Synergy ii us otw 2.25 x 20 mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found distal stent damage with stent struts lifted.The undamaged crimped stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the shaft polymer extrusion found a shaft polymer extrusion kink 32mm distal from the distal edge of the strain relief and 971mm distal from distal edge of the strain relief.No other issues were identified during the product analysis.
Additional Manufacturer Narrative
Device is a combination product.

• 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: 7947687
• Report Number: 2134265-2018-61740
• Device Sequence Number: 857356
• Product Code: NIQ
• UDI-Device Identifier: 08714729840626
• UDI-Public: 08714729840626
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 11/08/2018

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: 04/24/2020
• Device Model Number: 10611
• Device Catalogue Number: 10611
• Device Lot Number: 0022121101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1