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

Model Number	10603
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Injury (2348); Respiratory Failure (2484)
Date of Event	12/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that patient experienced hypotension and stent damage occurred.The target lesion was located in a coronary artery.After advancing the 300cm marvel guidewire, a 3.00 x 20mm synergy ii drug-eluting stent was advanced for treatment.However, the patient experienced low blood pressure.The stent was removed and the wire was repositioned.It was then noticed that the stent was unable to advanced over the wire and the tip was dragging the coating material off the wire.The procedure was completed with a different device and no further patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.Synergy ii us mr 3.00 x 20mm stent delivery system was returned for analysis.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 tactile examination of the hypotube found multiple hypotube kinks at several locations along the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.A visual and microscopic examination of the bumper tip found distal tip damage.A recommended 0.0140 guidewire loaded through the tip without issue.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that patient experienced hypotension and stent damage occurred.The target lesion was located in a coronary artery.After advancing the 300cm marvel guidewire, a 3.00 x 20mm synergy ii drug-eluting stent was advanced for treatment.However, the patient experienced low blood pressure.The stent was removed and the wire was repositioned.It was then noticed that the stent was unable to advanced over the wire and the tip was dragging the coating material off the wire.The procedure was completed with a different device and no further patient complications were reported.

• 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: 9570731
• Report Number: 2134265-2019-16604
• Device Sequence Number: 2436525
• Product Code: NIQ
• UDI-Device Identifier: 08714729840176
• UDI-Public: 08714729840176
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2021
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0024029549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: 12/24/2019
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other