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

Model Number	H7493941838300
Medical Device Problem Codes	Defective Device (2588); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent moved on the balloon requiring additional intervention.The patient presented with coronary artery disease and underwent a st elevation myocardial infarction (stemi) procedure of the target lesion located in the left anterior descending (lad) artery.A 3.00 x 38mm synergy xd drug-eluting stent was selected for use.Upon inspection of the device prior to use, there was no damage noticed on the device.During advancement of the device over the guidewire, there was no noticeable resistance noted.The stent was deployed successfully and was well-apposed.However, prior to deployment, it was noted that the balloon markers were not in proximity to the stent and angiogram showed that the balloon was longer than the stent.It was noted that there was roughly 10-12mm of balloon overhang between the proximal marker and the proximal edge of the stent.The physician decided to deploy the stent as the procedure was time sensitive and the patient was in critical condition.Although there were no issues with this stent, the physician decided that they needed to place a 3.50 x 12mm synergy xd drug-eluting stent proximal to the previously placed stent due to the balloon overhang.No patient complications were reported.

• 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: jeff wallner wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16800016
• Report Number: 2124215-2023-15889
• Device Sequence Number: 14265774
• Product Code: NIQ
• UDI-Device Identifier: 08714729981015
• UDI-Public: 08714729981015
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2023

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: 09/26/2024
• Device Model Number: H7493941838300
• Device Lot Number: 0030288411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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: Required Intervention
• Patient Sex: Unknown