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

Model Number	H7493941848250
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Codes	Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Perforation (2001)
Date of Event	01/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that difficulty removal, shaft break, and perforation occurred.The 100% stenosed target lesion was located in the severely tortuous and severely calcified mid right coronary artery (rca).A 2.50 x 48mm synergy xd drug-eluting stent was placed in the mid rca.However, the stent balloon would not pull back.The physician tried to remove the balloon but the shaft broke 25cm from the hypotube at the flexible distal portion.A balloon was placed distal to the broken shaft, inflated and dragged the broken device back into the guide.Furthermore, a perforation was noted at the mid rca.The patient became hypotensive and experienced chest pain.The perforation was treated with balloon tamponade.The procedure was prolonged but was able to be completed with a different device.No further patient but they were complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a synergy xd mr us 2.50 x 48mm stent delivery system was returned for analysis.The device was returned without the stent as it was implanted at the lesion site.The balloon cones were reviewed, and signs of positive pressure applied to them were noted as the balloon folds were noted to be relaxed and crimp stent markings were visible on the balloon body.A visual and microscopic examination of the bumper tip showed no signs of damage.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 found a break at the exchange port region of the shaft polymer extrusion.No other issues noted with device.
Event or Problem Description
It was reported that difficulty removal, shaft break, and perforation occurred.The 100% stenosed target lesion was located in the severely tortuous and severely calcified mid right coronary artery (rca).A 2.50 x 48mm synergy xd drug-eluting stent was placed in the mid rca.However, the stent balloon would not pull back.The physician tried to remove the balloon but the shaft broke 25cm from the hypotube at the flexible distal portion.A balloon was placed distal to the broken shaft, inflated and dragged the broken device back into the guide.Furthermore, a perforation was noted at the mid rca.The patient became hypotensive and experienced chest pain.The perforation was treated with balloon tamponade.The procedure was prolonged but was able to be completed with a different device.No further patient but they were complications were reported.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13295492
• Report Number: 2134265-2022-00410
• Device Sequence Number: 17352294
• Product Code: NIQ
• UDI-Device Identifier: 08714729985204
• UDI-Public: 08714729985204
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2023
• Device Model Number: H7493941848250
• Device Lot Number: 0027994048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Race: Black Or African American