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

Model Number	H7493941832500
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that balloon rupture occurred.A 5.00 x 32mm synergy xd drug-eluting stent was advanced for treatment.However, during procedure, it was noticed that there was a blood came back up into the endoflator which was attached to the monorail portion of the stent.When the device was pulled out, a hole in the balloon portion of the stent delivery system was noted.The procedure was completed with another stent and no patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 5.00 x 32mm synergy xd drug-eluting stent was advanced for treatment.However, during procedure, it was noticed that there was a blood came back up into the endoflator which was attached to the monorail portion of the stent.When the device was pulled out, a hole in the balloon portion of the stent delivery system was noted.The procedure was completed with another stent and no patient complications were reported.It was further reported that the 80%-90% stenosed, non-tortuous, eccentric target lesion was located in the mid right coronary artery.
Additional Manufacturer Narrative
B3 date of event was corrected from (b)(6) 2020.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11017916
• Report Number: 2134265-2020-17790
• Device Sequence Number: 19789016
• Product Code: NIQ
• UDI-Device Identifier: 08714729981299
• UDI-Public: 08714729981299
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 12/23/2020

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: 06/24/2022
• Device Model Number: H7493941832500
• Device Lot Number: 0025663506
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1