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

Lot Number 0030429043

Device Problem Failure to Advance (2524)

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

Event Date 12/19/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: synergy xd mr ous 3.00 x 32mm stent delivery system (sds) was returned for analysis.Visual examination identified the stent was not returned for detached and not returned product analysis.A visual and tactile examination identified multiple hypotube kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Bumper tip showed no signs of distal tip damage.Balloon cones were reviewed, and no issues were noted.The device was returned with the stent detached from the balloon.The stent outer diameter at the time of manufacturing was within maximum crimped stent profile measurement.

Event Description

Reportable based on device analysis completed on 23-feb-2024.It was reported that crossing difficulties were encountered.The target lesion was located in the left anterior descending artery.A 3.00 x 32mm synergy xd drug eluting stent was advanced for dilation.However, the stent failed to cross the lesion due to severe calcification.The procedure was completed with another of the same device sand no patient complications were reported.However, returned device analysis revealed stent detached.

• 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: 18894793
• MDR Text Key: 337555773
• Report Number: 2124215-2024-14959
• 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: 03/13/2024

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: 0030429043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• 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: 75 YR
• Patient Sex: Male