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

Model Number	10606
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 3.50 x 32 mm stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.Stent struts from the mid stent and proximal stent regions were lifted and pulled distally.The undamaged stent was measured and the result was 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 distal tip damage.A visual and tactile examination of the hypotube found multiple hypotube shaft kinks along the length of the hypotube shaft.A visual 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
Reportable based on device analysis completed on 05-aug-2020 it was reported that crossing difficulties were encountered.A 3.50 x 32mm synergy ii drug eluting stent was selected for use.However, due to highly calcified lesion, the stent could not cross the lesion.The procedure was completed with another of same device.There were no patient complications reported.Patient was stable.However, returned device analysis revealed stent damage.

• 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: 10459057
• Report Number: 2134265-2020-11808
• Device Sequence Number: 11497793
• Product Code: NIQ
• UDI-Device Identifier: 08714729840367
• UDI-Public: 08714729840367
• 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
• Report Date (Section B): 08/27/2020

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: 12/17/2021
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0024987272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1