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

Model Number 10619

Device Problems Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/19/2024

Event Type  Injury  

Event Description

It was reported that stent dislodgment and difficulty in position occurred requiring additional intervention.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending (lad) artery.After a non-boston scientific (bsc) guide catheter and a non-bsc guide wire were positioned, pre-dilation was performed with a 2.50 x 15 mm nc q apex balloon catheter and a synergy 2.50 x 24 mm stent was deployed distally.A 3.00 x 20 mm synergy drug-eluting stent was advanced for treatment in the proximal lad with overlap to the distal stent.The physician had difficulty placing the stent into the lesion and when attempted to remove it, the stent was dislodged from the delivery system.A parallel wire was then inserted, and a synergy 3.00 x 16 mm stent was deployed, crushing the dislodged stent and with overlap to the distal stent.The stent was then post dilated adequately.The procedure was completed, and no patient complications were reported.

• Brand Name: SYNERGY
• Type of Device: 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19122122
• MDR Text Key: 340336502
• Report Number: 2124215-2024-22800
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2024

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 Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0031901791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• 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 Sex: Male
• Patient Race: Asian