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

Model Number	10603
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.A 2.25 x 20mm synergy drug-eluting stent was selected for use.However, when the physician attempt to insert the stent, the shaft broke in half.The device was never entered into the patient's body.There were no patient complications reported and the patient was okay.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.25 x 20mm stent delivery system was returned for analysis.The distal end of the device including the lasercut hypotube, the midshaft, the polymer shaft, the balloon and the stent were not returned.The crimped stent outer diameter could not be measured as the distal end of the device containing the crimped stent was not returned.The maximum stent profile was within maximum crimped stent profile measurement.A visual and tactile examination of the hypotube found multiple hypotube kinks and a break 234mm distal to the distal end of the strain relief.Multiple kinks were also noted.A visual examination of the outer and inner lumen and mid-shaft section found no issues.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred.A 2.25 x 20mm synergy drug-eluting stent was selected for use.However, when the physician attempt to insert the stent, the shaft broke in half.The device was never entered into the patient's body.There were no patient complications reported and the patient was okay.

• 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: 9147976
• Report Number: 2134265-2019-11922
• Device Sequence Number: 19497203
• Product Code: NIQ
• UDI-Device Identifier: 08714729840145
• UDI-Public: 08714729840145
• 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): 12/04/2019

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 Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0023576506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1