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

Model Number H7493941838300

Device Problems Break (1069); Material Rupture (1546); Activation Failure (3270)

Patient Problems Hematoma (1884); Discomfort (2330); Foreign Body In Patient (2687)

Event Date 09/14/2021

Event Type  Injury  

Event Description

It was reported that balloon rupture, stent deployment issue and shaft break occurred, and the patient experienced discomfort and hematoma.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 3.00 x 38mm synergy xd drug-eluting stent was deployed for treatment.However, during the first inflation at 6 atmospheres, the balloon ruptured leaving behind partially deployed stent.The physician needed to recross stent and crush the stent against the side wall with additional stent.A shaft break was also noted 30mm distal from the tip.Furthermore, the patient experienced discomfort and hematoma.The stent delivery system was removed and the procedure was completed with a 3.0x38 non-boston scientific stent.No further patient complications were reported and the patient was stable post procedure.

• 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: 12555098
• MDR Text Key: 274044811
• Report Number: 2134265-2021-11970
• 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
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2023
• Device Model Number: H7493941838300
• Device Lot Number: 0027271619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 64