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

Lot Number 0030677275

Device Problems Fracture (1260); Failure to Advance (2524); 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 08/15/2023

Event Type  malfunction  

Event Description

It was reported that the stent fracture occurred.A 2.50 x 28mm synergy xd drug-eluting stent was advanced for treatment.However, during insertion of the device the stent fractured and would not pass.The device was removed by pulling, and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.

Manufacturer Narrative

H6: device code: changed to difficult to advance.Synergy xd mr ous 2.50 x 28mm stent delivery system was returned for analysis.A visual examination found multiple hypotube kinks along the hypotube shaft.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.The stent struts were damaged at the mid-section of the stent.Microscopic examination of the stent identified stent struts lifted at the mid-section of the stent.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Stent positioning examination revealed no signs of movement, the stent was set between the proximal and distal markerbands.The bumper tip showed no signs of distal tip damage.Dimensional analysis included measurement of the undamaged crimped stent outer diameter and the result was within max crimped stent profile measurement.No other issues were identified during analysis.

Event Description

It was reported that the stent fracture occurred.A 2.50 x 28mm synergy xd drug-eluting stent was advanced for treatment.However, during insertion of the device the stent fractured and would not pass.The device was removed by pulling, and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.

• 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: 17715759
• MDR Text Key: 323069743
• Report Number: 2124215-2023-44875
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

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: 0030677275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2022
• 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