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

Model Number	10605
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the coronary artery.A 3.00 x 28mm synergy drug-eluting stent was advanced for treatment.However, during procedure, it was noticed that the stent strut got fractured.The device was removed from the patient's body.No patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 3.00 x 28 mm stent delivery system was returned for analysis.The stent was visually examined, and stent struts were noted to be lifted and pulled in distal direction.The stent showed no signs of movement and was set between the distal and proximal markerbands.An undamaged section of the crimped stent od was measured and the result was within max crimped stent profile measurement.The balloon cones were reviewed, and no visible defects were noted.The balloon wings were tightly wrapped and evenly folded and there were no signs of positive pressure.A visual and microscopic examination of the bumper tip identified damage to the distal edge of the tip.A visual and tactile examination of the hypotube identified multiple kinks along the length of the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the polymer extrusion shaft.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the coronary artery.A 3.00 x 28mm synergy drug-eluting stent was advanced for treatment.However, during procedure, it was noticed that the stent strut got fractured.The device was removed from the patient's body.No patient complications were reported and the patient was fine.It was further reported that the procedure was completed with another synergy 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: 8831146
• Report Number: 2134265-2019-08767
• Device Sequence Number: 2390136
• Product Code: NIQ
• UDI-Device Identifier: 08714729840299
• UDI-Public: 08714729840299
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 08/27/2019

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: 05/12/2021
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0023800040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1