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

Lot Number 0028006143

Device Problem Migration (4003)

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

Event Date 04/06/2022

Event Type  malfunction  

Event Description

It was reported that stent migration occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.After pre-dilation was performed with a 2.5 x 15 maverick balloon catheter, a 3.00 x 24mm synergy xd drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent strut was caught and stent migrated due to calcification.The procedure was completed and there were no patient complications reported and the patient was stable.

Event Description

It was reported that stent migration occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.After pre-dilation was performed with a 2.5 x 15 maverick balloon catheter, a 3.00 x 24mm synergy xd drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent strut was caught and stent migrated due to calcification.The procedure was completed and there were no patient complications reported and the patient was stable.

Manufacturer Narrative

Device evaluated by mfr.: synergy xd mr 3.00 x 24mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Proximal struts were found to be lifted and folded distally.The undamaged stent outer diameter was measured and the result was within max 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 distal tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during 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: 14088762
• MDR Text Key: 289187276
• Report Number: 2134265-2022-04312
• 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,Followup
• Report Date: 06/21/2022

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: 08/31/2023
• Device Lot Number: 0028006143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 06/16/2022
• Supplement Dates FDA Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• 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: 75 YR
• Patient Sex: Male