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

Model Number	10607
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: the event occurred 2-3 days prior to (b)(6) 2019.Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the very tortuous right coronary artery (rca).A 2.75 x 38mm synergy ii drug-eluting stent was advanced for treatment.However, after multiple attempts to pass the ostium of the rca, the shaft bent.The catheter was snapped before putting in the device box.The procedure was completed with another of the same device.No patient complications were reported and patient status was fine.
Additional Manufacturer Narrative
(b3) date of event: the event occurred 2-3 days prior to (b)(6) 2019.Device is a combination product.A synergy ii us mr 2.75 x 38 mm stent delivery system (sds) from was returned for analysis broke in 2 pieces.The second piece of this device containing the manifold hub was not returned.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent od (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 signs of damage on the distal end of the tip.A visual and tactile examination of the hypotube shaft found a break situated at 86 cm proximal to the distal end of the tip.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen 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 shaft break occurred.The target lesion was located in the very tortuous right coronary artery (rca).A 2.75 x 38mm synergy ii drug-eluting stent was advanced for treatment.However, after multiple attempts to pass the ostium of the rca, the shaft bent.The catheter was snapped before putting in the device box.The procedure was completed with another of the same device.No patient complications were reported and patient status was fine.

• 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: 8811371
• Report Number: 2134265-2019-08545
• Device Sequence Number: 11376902
• Product Code: NIQ
• UDI-Device Identifier: 08714729840404
• UDI-Public: 08714729840404
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 09/13/2019

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: 01/20/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0023251781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1