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 Patient Involvement (2645)
Date of Event	04/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.75 x 24mm stent delivery system (sds) was returned for analysis.Visual and microscopic examination of the stent found stent damage to stent strut rows 9 and 10 from proximal stent, with stent struts raised.The undamaged 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.Visual and microscopic examination of the bumper tip showed no signs of damage.Visual and tactile examination of the hypotube found multiple hypotube kinks at several locations along the length of the hypotube.Visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2019.It was reported that shaft kink occurred.A 2.75 x 24 synergy ii drug-eluting stent was selected for use.However, during unpacking, a kink on the shaft of the stent was noted.Another of the same device was opened and completed the procedure.No patient complications were reported.However, device analysis revealed a stent damage.

• 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: 8716181
• Report Number: 2134265-2019-06455
• Device Sequence Number: 2004168
• Product Code: NIQ
• UDI-Device Identifier: 08714729840220
• UDI-Public: 08714729840220
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2019

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: 11/25/2020
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0023027697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1