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

Model Number	10607
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 4.00 x 38 mm stent delivery system was returned for analysis.A visual examination of the stent found that the device was returned inside the guide catheter.The stent was damaged on the proximal section of the stent with stent struts pushed distally and bunched at the distal end of the guide catheter and the stent struts from the 1st distal row was slightly open.The undamaged stent od (outer diameter) was measured and the result 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 no signs of damage.A visual and tactile examination of the hypotube multiple kinks along several locations of the hypotube shaft that was not covered by the guide catheter.This type of damage is consistent with excessive force that could have been applied on the delivery system.A visual and tactile examination of the outer and inner lumen and mid-shaft section could not be performed as the analyst failed to remove the device from the guide catheter, however, at final inspection, visual and tactile examination of the shaft is performed and if any defects are noted, the device will be rejected.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 21-mar-2019.It was reported that crossing difficulties were encountered.The target lesion was located in a coronary vessel.A 4.00x38mm synergy drug-eluting stent was advanced but failed to cross the lesion.No patient complications were reported.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: 8504739
• Report Number: 2134265-2019-03764
• Device Sequence Number: 10812556
• Product Code: NIQ
• UDI-Device Identifier: 08714729840435
• UDI-Public: 08714729840435
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/11/2019

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: 06/13/2020
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 22272374
• 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: 03/21/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1