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

Model Number 10621

Device Problems Difficult or Delayed Positioning (1157); Material Deformation (2976); Activation Failure (3270)

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

Event Date 12/01/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter address 1:(b)(6).

Event Description

It was reported that inadequate apposition requiring intervention occurred.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.Following pre-dilation with a 2.0 x 15 balloon catheter, a 4.00 x 28 synergy ii drug-eluting stent was implanted.However, the distal end of the stent was not fully apposed to the vessel wall.The proximal end rubbed against the edge of the stent.After repeated adjusting of the position of the stent, the deployment was still not optimized.The device was withdrawn, and it was found that the metal wire at the distal end of the stent was deformed.The procedure was completed with another of same device.No patient complications were reported, and the patient status was stable.

• Brand Name: SYNERGY
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16355645
• MDR Text Key: 309314484
• Report Number: 2124215-2023-05401
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2023
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0028182936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 59 KG