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

Lot Number 0028113884

Device Problem Failure to Advance (2524)

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

Event Date 02/21/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 13-apr-2022.It was reported that crossing difficulties were encountered.The 92% stenosed target lesion was located in the severely tortuous and severely calcified mid left anterior descending artery.A 3.00 x 48mm synergy xd drug eluting stent was advanced for treatment but failed to cross the lesion.The procedure was completed with a different device.No patient complications were reported.However, returned device analysis revealed stent damage.

Manufacturer Narrative

Device evaluated by mfr.: a synergy xd mr ous 3.00 x 48mm stent delivery system was returned for analysis.A visual examination of the stent found mid-stent damage, with stent struts listed.The undamaged crimped stent outer diameter was measured using snap gauge and the result was within maximum crimped stent profile measurement.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.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple hypotube kinks at several locations along the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14242230
• MDR Text Key: 290372936
• Report Number: 2134265-2022-04572
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2022

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 Expiration Date: 09/22/2023
• Device Lot Number: 0028113884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2021
• 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: 84 YR
• Patient Sex: Male