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

Model Number	10601
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
Reportable based on device analysis completed on 28-nov-2018.It was reported that crossing difficulties were encountered.The target lesion was located in a coronary artery.A 2.25 x 12mm synergy ii drug-eluting stent was advanced but failed to cross the lesion.The device was removed and the procedure was completed with a different device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed a hypotube detached/separated.A synergy ii us mr 2.25 x 12mm stent delivery system (sds) 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 outer diameter (od) was measured and is 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 damage.A visual and tactile examination of the hypotube found a break 850mm distal to the distal end of the strain relief.A visual and tactile examination of the outer and inner lumen and mid-shaft found no issues.No other issues were identified during the product analysis.

• 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: 8170037
• Report Number: 2134265-2018-64419
• Device Sequence Number: 1459112
• Product Code: NIQ
• UDI-Device Identifier: 08714729840022
• UDI-Public: 08714729840022
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 12/17/2018

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: 07/15/2020
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0022410305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR