MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number	10619
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified mid circumflex artery.A 4.50 x 20 synergy drug-eluting stent was selected for treatment.Upon insertion, it was noted that the physician kinked the catheter shaft slightly but proceeded to insert the device.However, the hypotube fractured and separated itself from the proximal portion of the catheter.The device was completely removed via the guide catheter.The procedure was completed successfully with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified mid circumflex artery.A 4.50 x 20 synergy drug-eluting stent was selected for treatment.Upon insertion, it was noted that the physician kinked the catheter shaft slightly but proceeded to insert the device.However, the hypotube fractured and separated itself from the proximal portion of the catheter.The device was completely removed via the guide catheter.The procedure was completed successfully with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device is a combination product.Corrections: initial reporter facility name corrected to (b)(6) hospital initial reporter address 1 corrected to (b)(6).Initial reporter city corrected to (b)(6).Initial reporter zip/post code corrected to (b)(6).Initial reporter phone corrected to +(b)(6).

• Brand Name: SYNERGY
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8627313
• Report Number: 2134265-2019-05555
• Device Sequence Number: 2257346
• Product Code: NIQ
• UDI-Device Identifier: 08714729973362
• UDI-Public: 08714729973362
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P150003/S039
• 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): 06/13/2019

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: 11/04/2020
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0022914482
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1