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

Lot Number 0030804772

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/23/2023

Event Type  malfunction  

Event Description

It was reported that stent move on balloon occurred.Vascular access was obtained via the radial artery.The 47mmx2.5mm, eccentric, de novo target lesion containing a <=45 degrees bend was located in the mildly tortuous and moderately calcified left anterior descending artery and left circumflex artery.Following pre-dilatation with a 2.5x15 balloon catheter, a 2.50 x 48mm synergy xd drug-eluting stent was advanced for treatment.However, during advancing, resistance was encountered and had difficulty in navigating across the lesion.The device was removed, and it was noticed that the stent was moved from the balloon but was still within the balloon area.The procedure was completed with a different device.No patient complications were reported, and the patient status was stable.

Manufacturer Narrative

The synergy xd mr ous 2.50 x 48mm stent delivery system was returned for analysis.Visual/tactile inspection revealed multiple hypotube kinks, no issues with the outer/mid-shaft sections or inner lumen of the device, distal stent strut damage with struts lifted and pulled distally over the distal markerband and balloon cone, and balloon cones having been subjected to positive pressure.Microscopic inspection revealed no sign of movement at the proximal end of the stent and no signs of distal tip damage.The undamaged crimped stent od (outer diameter) was measured within max crimped stent profile measurement.The device could be loaded and tracked over a 0.014 in guidewire without issue.

Event Description

It was reported that stent move on balloon occurred.Vascular access was obtained via the radial artery.The 47mmx2.5mm, eccentric, de novo target lesion containing a <=45 degrees bend was located in the mildly tortuous and moderately calcified left anterior descending artery and left circumflex artery.Following pre-dilatation with a 2.5x15 balloon catheter, a 2.50 x 48mm synergy xd drug-eluting stent was advanced for treatment.However, during advancing, resistance was encountered and had difficulty in navigating across the lesion.The device was removed, and it was noticed that the stent was moved from the balloon but was still within the balloon area.The procedure was completed with a different device.No patient complications were reported, and the patient status was stable.

• 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: 17715261
• MDR Text Key: 323009841
• Report Number: 2124215-2023-46858
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: TW
• 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,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0030804772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2022
• 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