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

Model Number	10602
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent damage occurred.The 80% stenosed target lesion was located in the severely tortuous and moderately calcified left internal mammary artery.A 2.25 x 16 synergy drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent strut was damaged.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.25 x 16 mm stent delivery system was returned for analysis broken and without the proximal section of the hypotube.A visual examination of the stent found signs of stent damage.Stent struts on the 1st proximal stent strut row was noted to be lifted and pulled in a distal direction.The undamaged stent outer dimater was measured and the result was within max crimped stent profile measurement.Proximal 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 signs of damage on the distal end of the tip.Tip damage most likely occurred when the tip was pushed against a restriction.A visual and tactile examination of the hypotube shaft found a break situated at 46 cm proximal to the distal end of the tip.The proximal end of the device with the manifold hub was not returned for analysis.A kink was noted on the hypotube shaft immediately below the breaking site (45 cm proximal to the distal end of the tip).This type of damages most likely occurred due to excessive forces that could have been applied on the delivery system.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.The 80% stenosed target lesion was located in the severely tortuous and moderately calcified left internal mammary artery.A 2.25 x 16 synergy drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent strut was damaged.No patient complications were reported.It was further reported that the hypotube broke during insertion.

• 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: 8845797
• Report Number: 2134265-2019-08788
• Device Sequence Number: 242856
• Product Code: NIQ
• UDI-Device Identifier: 08714729840084
• UDI-Public: 08714729840084
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 09/04/2019

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: 02/19/2021
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0023413511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1