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

Lot Number 0028934936

Device Problem Failure to Advance (2524)

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

Event Date 02/11/2024

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 22mar2024.It was reported that crossing difficulties occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified distal right coronary artery.A 3.00 x 16mm synergy xd drug eluting stent was advanced for treatment but failed to pass through the lesion.The procedure was completed with 3.0x20 non-boston scientific device.No patient complications were reported, and the patient was good.However, returned device analysis revealed hypotube break.

Manufacturer Narrative

Device evaluated by mfr: synergy xd mr ous 3.00 x 16mm stent delivery system was returned for analysis.A visual and tactile examination of the hypotube found multiple kinks and a break at 26cm distal to the distal end of the strain relief.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.Microscopic analysis examination of the crimped stent via scope found evidence of stent damage with the stent struts lifted at the mid-section.No signs of movement, stent was set between the proximal and distal markerbands.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.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.

• 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: 18999592
• MDR Text Key: 338945729
• Report Number: 2124215-2024-18069
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2024
• Device Lot Number: 0028934936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Male