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

Model Number	H7493941824270
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Chest Pain (1776); Respiratory Arrest (4461); Insufficient Information (4580)
Date of Event	03/24/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.The patient underwent percutaneous coronary intervention (pci) with the deployment of a 2.75 x 24 mm synergy xd drug-eluting stent.During the procedure, the balloon shaft fractured proximal to the mid-left anterior descending (lad) artery post-deployment.Although the stent was successfully deployed, the balloon could not be removed.The fractured device was extracted using a snare.After the removal, the patients condition deteriorated rapidly.A full code was initiated in an attempt to stabilize the patient, but despite all resuscitative efforts, the patient passed away.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, such as how many seconds did the user allow for the balloon to deflate prior to attempting to withdraw but further information was unable to be obtained.
Additional Manufacturer Narrative
B5 - describe event or problem: updated to include new information obtained.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, such as how many seconds did the user allow for the balloon to deflate prior to attempting to withdraw but further information was unable to be obtained.
Event or Problem Description
It was reported that the patient died.The patient underwent percutaneous coronary intervention (pci) with the deployment of a 2.75 x 24mm synergy xd drug-eluting stent.During the procedure, the balloon shaft fractured proximal to the mid-left anterior descending (lad) artery post-deployment.Although the stent was successfully deployed, the balloon could not be removed.The fractured device was extracted using a snare.After the removal, the patients condition deteriorated rapidly.A full code was initiated in an attempt to stabilize the patient, but despite all resuscitative efforts, the patient passed away.It was further reported via medwatch mw5153914 that the procedure began with vascular access through the right groin.Diagnostic imaging identified a 95% stenosed target lesion located in the mildly tortuous and severely calcified proximal to mid segment of the left anterior descending (lad) artery.The lesion was pre-dilated using a 2.0 x 20 mm non-boston scientific balloon catheter.A stent was then deployed at 20 atmospheres.During deployment, the stent failed to fully expand, and the balloon could not be withdrawn.Angiography revealed that the balloon markers had been left within the vessel.The patient began experiencing chest discomfort and was intubated.Although the retained balloon markers were successfully retrieved, the patients condition continued to deteriorate, leading to cardiac and respiratory arrest.Cardiopulmonary resuscitation (cpr) was initiated, and an attempt was made to place an impella device, but it was unsuccessful.The patient died.

• Brand Name: SYNERGY? XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21840294
• Report Number: 2124215-2025-21909
• Device Sequence Number: 20984399
• Product Code: NIQ
• UDI-Device Identifier: 08714729980902
• UDI-Public: (01)08714729980902(17)260415(10)33881804
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: 04/15/2026
• Device Model Number: H7493941824270
• Device Catalogue Number: H7493941824270
• Device Lot Number: 0033881804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 05/12/2025
• Date Device Manufactured: 04/15/2024
• 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: Death
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 124 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White