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

Model Number	10607
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is as combination product.Date of event: estimated based on aware date of (b)(6) 2019.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in very calcified coronary artery.A 2.50 x 38mm synergy ii drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion and after removal the stent was noted to be folded.There were no complications and the patient status was stable.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in very calcified coronary artery.A 2.50 x 38mm synergy ii drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion and after removal the stent was noted to be folded.There were no complications and the patient status was stable.It was further reported that the target lesion was located in the left anterior descending artery.
Additional Manufacturer Narrative
B3: date of event updated.B5: describe event or problem updated.Device is as combination product.
Additional Manufacturer Narrative
B3: date of event updated.B5: describe event or problem updated.Device is as combination product.Device evaluated by mfr.:synergy ii us mr 2.50 x 38mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Stent struts on the distal region were noted to be lifted and stretched in a distal direction over the distal balloon cone.The undamaged stent outer diameter was measured and the result is 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 damage to distal end of tip.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile 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
It was reported that stent damage occurred.The target lesion was located in very calcified coronary artery.A 2.50 x 38mm synergy ii drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion and after removal the stent was noted to be folded.There were no complications and the patient status was stable.It was further reported that the target lesion was located in the left anterior descending artery.

• 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: 9490411
• Report Number: 2134265-2019-15941
• Device Sequence Number: 19578402
• Product Code: NIQ
• UDI-Device Identifier: 08714729840398
• UDI-Public: 08714729840398
• Combination Product (Y/N): N
• Initial Reporter Country: RQ
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2020

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: 08/18/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0024325405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 12/26/2019; 02/26/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 01/14/2020; 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1