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

Lot Number 0028788483

Device Problem Failure to Advance (2524)

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

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter phone: (b)(6).Device evaluated by mfr: synergy xd mr ous 3.50 x 48mm stent delivery system (sds), was returned for analysis.Visual / tactile inspection identified that the stent had been detached from the delivery system and not returned.No issues identified with the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section identified no issues.Microscopic analysis the balloon cones were reviewed, and no issues were noted.Bumper tip showed no signs of distal tip damage.Dimensional testing the device was returned without the stent attached.The stent od (outer diameter) at the time of manufacturing was 0.0437, this is within maximum crimped stent profile measurement.

Event Description

Reportable based on devices analysis completed on 29feb2024.It was reported that crossing difficulties occurred.The 80% stenosed target lesion was located in the severely tortuous and mildly calcified left circumflex artery (lcx).A 3.50 x 48mm synergy xd drug eluting stent was advanced for treatment.However, during the procedure, the device failed to cross the lesion site due to angulation.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed the stent was detached from the delivery system.

• 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: 18932403
• MDR Text Key: 338131606
• Report Number: 2124215-2024-13444
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2024
• Device Lot Number: 0028788483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2022
• 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: 67 YR
• Patient Sex: Male