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

Model Number	H7493941832250
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.This 2.50 x 32mm synergy xd was used for a percutaneous coronary intervention in the right coronary artery.The balloon ruptured after deploying the stent.No patient complications occurred.
Event or Problem Description
It was reported that balloon rupture occurred.This 2.50 x 32mm synergy xd was used for a percutaneous coronary intervention in the right coronary artery.The balloon ruptured after deploying the stent.No patient complications occurred.It was further reported that the balloon was inflated to 11 atmospheres.
Additional Manufacturer Narrative
A 2.50 x 32mm synergy xd stent delivery system was returned for analysis.No stent was attached to the balloon and the balloon appeared to have been inflated with a blood like substance inside the balloon.A visual and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found multiple kinks along the length 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 a kink fracture 365mm proximal to the distal tip, with both sections being held together by the core wire.Examination of the hub and strain relief via scope did not identify any issues.The device was loaded onto a 0.0140 inch guidewire without issue and then attached to encore inflation device.An attempt was then made to inflate the balloon to 18atm, however, pressure was unable to maintained above 2atm as inflation liquid was observed leaking from the kink fracture site in the lasercut section of the shaft.The shaft of the device was cut 360mm proximal to the distal tip to allow for inflation aid to be attached.The inflation aid was then attached to the cut shaft and the encore inflation device attached to the inflation aid.The balloon was then inflated to 18atm without issue.A vacuum was pulled using the encore device and the balloon deflated fully.The encore device was verified before and after the procedure.No other issues were identified during the product analysis.

• 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: 10771805
• Report Number: 2134265-2020-14350
• Device Sequence Number: 4141214
• Product Code: NIQ
• UDI-Device Identifier: 08714729980841
• UDI-Public: 08714729980841
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: H7493941832250
• Device Lot Number: 0025664919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR