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

Model Number (GTIN) 08714729981251

Device Problems Migration or Expulsion of Device (1395); Retraction Problem (1536); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/02/2023

Event Type  Injury  

Event Description

After the deployment of the synergy xd monorail everolimus-eluting platinum chromium coronary stent system, the balloon would not pull back into the guide catheter.Multiple attempts were made by the interventional cardiologist to deflate the balloon and remove the balloon and wire.The balloon of the synergy xd monorail everolimus-eluting platinum chromium coronary stent system detached from the catheter.A small segment (<1mm in size) of the balloon marker became detached from the balloon and was unable to be retrieved from the right coronary artery.The interventional cardiologist was able to retrieve the severed balloon, utilizing the patient's femoral vein as the balloon had migrated below the patient's knee.The small portion of the balloon marker was unable to be retrieved by the interventional cardiologist and remained in the rca.The interventional cardiologist documented the tip of the balloon marker did not require additional attempts to remove as it is very small, and the patient will be treated medically.

• Brand Name: SYNGERY XD MONORAIL
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 16372260
• MDR Text Key: 309587608
• Report Number: MW5114904
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2023
• Device Model Number: (GTIN) 08714729981251
• Device Catalogue Number: H7493941816500
• Device Lot Number: 28534209
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White