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

Model Number	10604
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2020
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 target lesion was located in the coronary artery.A 2.50 x 24 synergy drug-eluting stent was advanced for treatment.However, during procedure, it failed to cross the lesion and it was noticed that the stent itself was damaged.The device was completely removed and the procedure was completed with a different device.There were no patient complications nor injuries reported and the patient was fine.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the coronary artery.A 2.50 x 24 synergy drug-eluting stent was advanced for treatment.However, during procedure, it failed to cross the lesion and it was noticed that the stent itself was damaged.The device was completely removed and the procedure was completed with a different device.There were no patient complications nor injuries reported and the patient was fine.It was further reported that the target lesion is located in the non-tortuous and heavily calcified proximal right coronary artery.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: synergy ii us mr 2.50 x 24 mm stent delivery system was returned for analysis.An examination of the crimped stent found that the stent was damaged on its entire length with struts lifted from their crimped position and pulled distally.The three most proximal stent strut rows were noted to be undamaged.A review of the manufacturing stent profile data was performed and the stent at the time of manufacture was within max 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 damage at the distal end of the tip.A visual and tactile examination of the hypotube shaft found multiple kinks along several locations of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.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: 9763789
• Report Number: 2134265-2020-02209
• Device Sequence Number: 16269562
• Product Code: NIQ
• UDI-Device Identifier: 08714729840213
• UDI-Public: 08714729840213
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2020

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: 05/28/2021
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0023933114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1