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

Model Number	H7493941824350
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Chest Pain (1776); Non specific EKG/ECG Changes (1817)
Date of Event	05/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter address: (b)(6).
Event or Problem Description
It was reported that stent fracture, chest pain, and st segment elevation occurred.The target lesion was located in the mildly tortuous and moderately calcified proximal left anterior descending artery (lad).A 3.50 x 24mm synergy xd drug-eluting stent was advanced for direct stenting.Following stent implantation, post dilation was performed with a 3.5 nc emerge balloon catheter.A hazy spot was seen within the mid portion of the stent and it was thought that the stent had fractured.The patient started having chest pain and st elevation, so two non-boston scientific stents were placed in the hazy area where the stent was thought to be fractured and the procedure was completed.The patient immediately started recovering.The patient was fully recovered and discharged the next day.
Additional Manufacturer Narrative
E1- initial reporter address 1: (b)(6).The device was not returned, therefore device analysis could not be performed.A review of a short angiographic video and two angiographic images provided by the site was performed.The two images showed a deployed stent in left anterior descending artery (lad) without flow contrast.A narrowing was noted in the distal section of the deployed stent but no gaps suggesting stent deformation were observed.The second still image showed the narrowing to be resolved.The two second video clip showed views under flow contrast of the left main arteries with the distal end of the guidecatheter also visible at the left main ostium.The stent was shown deployed on a bend traversed by a guidewire.The contrast assessment shot did not show any restricted or hazy flow regions.The review could not identify the alleged stent fracture as no strut displacement was noted on the lad deployed stent.A constricted region was noted on the distal section of the stent but this was noted to be resolved in a second photo provided by the customer.The short clip shows good flow movement within the left main arteries and no deformation of the deployed stent in lad.
Event or Problem Description
It was reported that stent fracture, chest pain, and st segment elevation occurred.The target lesion was located in the mildly tortuous and moderately calcified proximal left anterior descending artery (lad).A 3.50 x 24mm synergy xd drug-eluting stent was advanced for direct stenting.Following stent implantation, post dilation was performed with a 3.5 nc emerge balloon catheter.A hazy spot was seen within the mid portion of the stent and it was thought that the stent had fractured.The patient started having chest pain and st elevation, so two non-boston scientific stents were placed in the hazy area where the stent was thought to be fractured and the procedure was completed.The patient immediately started recovering.The patient was fully recovered and discharged the next day.

• 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: 14472832
• Report Number: 2134265-2022-05482
• Device Sequence Number: 4516152
• Product Code: NIQ
• UDI-Device Identifier: 08714729981060
• UDI-Public: 08714729981060
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 06/13/2022

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: 05/11/2023
• Device Model Number: H7493941824350
• Device Lot Number: 0027372349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• 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 Sex: Unknown