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

Model Number	10604
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
Reportable based on device analysis completed on 19-dec-2018.It was reported that difficulty loading wire occurred.During introduction of a 2.25 x 24mm synergy ii drug-eluting stent into the wire, the device would not go over the wire.Another 2.25 x 24mm synergy stent was used and the procedure was completed.No patient complications or injuries were reported.However, returned device analysis revealed a stent damage.A synergy ii us mr 2.25 x 24mm stent delivery system (sds) was returned for analysis without a stent.A visual and microscopic examination of the crimped identified stent damage.The crimped stent outer diameter (od) of the undamaged section of the crimped stent was measured and is within max crimped stent profile measurement.The balloon was 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.A visual and tactile examination of the shaft polymer extrusion revealed no issues.The device was loaded onto and tracked over a 0.014 guidewire without issue.A visual and microscopic examination found damage to the tip.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: 8156767
• Report Number: 2134265-2018-63617
• Device Sequence Number: 295351
• Product Code: NIQ
• UDI-Device Identifier: 08714729840206
• UDI-Public: 08714729840206
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 12/12/2018

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: 04/10/2019
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0022035056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1