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

Model Number	10603
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Synergy ii us mr 2.75 x 20mm distal portion of the stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent od(outer diameter) was measured and the result was within max 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 no signs of damage.A visual and tactile examination of the hypotube found a break 69cm distal to the distal end of the strain relief.Multiple kinks were also noted.The mid-shaft section was detached and not returned.A visual and tactile examination of the mid-shaft, outer and inner lumen of the shaft polymer extrusion found no issues.
Event or Problem Description
Reportable based on device analysis completed on 05mar2019.It was reported that crossing difficulties were encountered.During a percutaneous coronary intervention (pci), a 2.75 x 20 mm synergy stent was advanced but failed to cross the lesion.No patient complications were reported.However, device analysis revealed a hypotube break.

• 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: 8438023
• Report Number: 2134265-2019-02786
• Device Sequence Number: 1785983
• Product Code: NIQ
• UDI-Device Identifier: 08714729840169
• UDI-Public: 08714729840169
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2019

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: 10/30/2020
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 22914485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/20/2019
• Patient Sequence Number: 1