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

Model Number H7493941848400

Device Problems Entrapment of Device (1212); Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2022

Event Type  malfunction  

Event Description

It was reported that stent dislodgement occurred.The target lesion was located in the right coronary artery.A 4.00 x 48mm synergy xd drug-eluting stent was advanced through a guidezilla ii guide extension catheter for treatment.When the stent delivery system (sds) advanced to the guide catheter, it got stuck at the collar and the stent was stripped from the balloon.The sds and the dislodged stent were removed together with the guide catheter.Another 4.00 x 48mm synergy xd was advanced but the same issue occurred.The procedure was completed by replacing the guide extension catheter.No patient complications were reported.

• Brand Name: SYNERGY XD
• Type of Device: 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: 14835970
• MDR Text Key: 301643215
• Report Number: 2134265-2022-06961
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729985242
• UDI-Public: 08714729985242
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Model Number: H7493941848400
• Device Lot Number: 0028137922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: GUIDEZILLA