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

Model Number H7493941838300

Device Problems Positioning Failure (1158); Difficult to Remove (1528); Material Rupture (1546)

Event Date 03/01/2022

Event Type  Injury  

Event Description

It was reported that balloon rupture occurred and removal difficulties were encountered.A 3.00 x 38mm synergy xd drug-eluting stent was advanced for treatment.However, as the stent was being deployed, the balloon burst and pulled blood into the inflation device.The physician noticed that the proximal and distal edges of stent expanded but the rest did not.The stent could not be removed or inflated.The hub was cut and a guidezilla2 guide extension catheter was introduced to successfully recapture the stent.The procedure was completed with another of same device.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: 13766602
• MDR Text Key: 287196315
• Report Number: 2134265-2022-02809
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981015
• UDI-Public: 08714729981015
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Report Date: 03/14/2022

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2023
• Device Model Number: H7493941838300
• Device Lot Number: 0027548932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial