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

Model Number	10604
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
Reportable based on device analysis completed on 12-sep-2018.It was reported that crossing difficulties were encountered.The target lesion was located in the highly calcified left anterior descending artery.A 2.25 x 24mm synergy ii drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed stent damage.A synergy ii us mr 2.25 x 24 mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found proximal stent damage on the 4th proximal stent strut row, a stent strut was lifted.The undamaged distal section stent outer diameter (od) was measured and is within maximum crimped stent profile measurement.Stent damage most likely occurred during withdrawal attempts.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 multiple kinks along several locations of the hypotube shaft.This type of damage noted most likely occurred due to 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 found kink at port bond.This type of damage noted most likely occurred due to excessive force that could have been applied on the delivery system.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: 7945004
• Report Number: 2134265-2018-61706
• Device Sequence Number: 857278
• Product Code: NIQ
• UDI-Device Identifier: 08714729840206
• UDI-Public: 08714729840206
• 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): 10/08/2018

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: 11/30/2018
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0021474767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR