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

Lot Number 0029596705

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/30/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 30-aug-2022.It was reported that device damage occurred.A 4.00 x 48mm synergy xd drug-eluting stent was selected for treatment, but the device was noted to be damaged.No patient complications were reported.However, returned device analysis revealed stent detachment.

Manufacturer Narrative

Device evaluated by mfr: synergy xd mr us 4.00 x 48mm stent delivery system (sds) was returned for analysis.Visual/tactile, microscopic and dimensional analyses were performed on the device.The stent was returned detached from the device.Damage along the entire length of the stent was noted with the stent struts pulled and stretched evidencing excessive tensile force applied to the stent.A stent od reading couldn't be obtained.A review of the manufacturing stent profile data was performed and the stent od at the time of manufacture was 0.0484 inches which is within specification.Balloon cones were reviewed where it was subjected to positive pressure.No issues were identified with the hypotube shaft.No issues were identified with the outer/mid-shaft sections or the inner lumen of the device.Bumper tip showed no signs of distal tip damage.

• Brand Name: SYNERGY XD
• 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: 17811044
• MDR Text Key: 324177393
• Report Number: 2124215-2023-47998
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729985242
• UDI-Public: 08714729985242
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0029596705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2022
• 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