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

Model Number 10632

Device Problems Failure to Advance (2524); Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/25/2021

Event Type  malfunction  

Event Description

It was reported that foreign materials were found on the stent.The target lesion was located in a coronary artery.A 2.50 x 48 synergy drug-eluting stent was opted for use to treat the lesion.The stent was prepared and introduced into the guide catheter and was advanced to the coronary artery.The physician struggled to pass the stent through the lesion adn decided to pre-dilate the vessel.The device was removed and was placed on the sterile drape.After pre-dilating the vessel, the physician took the synergy stent off the drape and it was noticed that ther were light fibers stuck on the stent.The physician was not sure what it was and chose to use another stent to complete the procedure.No patient complications were reported and the patient status was stable.

Manufacturer Narrative

Updated b5: describe event or problem.

Event Description

It was reported that foreign materials were found on the stent.The target lesion was located in a coronary artery.A 2.50 x 48 synergy drug-eluting stent was opted for use to treat the lesion.The stent was prepared and introduced into the guide catheter and was advanced to the coronary artery.The physician struggled to pass the stent through the lesion adn decided to pre-dilate the vessel.The device was removed and was placed on the sterile drape.After pre-dilating the vessel, the physician took the synergy stent off the drape and it was noticed that ther were light fibers stuck on the stent.The physician was not sure what it was and chose to use another stent to complete the procedure.No patient complications were reported and the patient status was stable.It was further reported that the target lesion was 90% stenosed and was located in the non tortuous and moderately calcified left anterior descending artery.

Manufacturer Narrative

Device evaluated by mfr: synergy ous mr 2.50 x 48 mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent outer diameter was measured using a 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 white gauze/medical tape like substance attached to hypotube 42 cm proximal to the distal tip.Fibers were noted intertwined with the stent struts thought the length of the stent and they were analyzed using an fourier transform infra-red spectroscopy (ftir) analytical instrument.These synthetic fibrous materials are known to be composites of disposable surgical drapes, surgical gowns, and other surgical staff apparel.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.An engineer from the stent delivery catheter (sdc) production unit was present to review the mid-shaft bond and deemed it as acceptable.No other issues were identified during the product analysis.

Event Description

It was reported that foreign materials were found on the stent.The target lesion was located in a coronary artery.A 2.50 x 48 synergy drug-eluting stent was opted for use to treat the lesion.The stent was prepared and introduced into the guide catheter and was advanced to the coronary artery.The physician struggled to pass the stent through the lesion adn decided to pre-dilate the vessel.The device was removed and was placed on the sterile drape.After pre-dilating the vessel, the physician took the synergy stent off the drape and it was noticed that ther were light fibers stuck on the stent.The physician was not sure what it was and chose to use another stent to complete the procedure.No patient complications were reported and the patient status was stable.It was further reported that the target lesion was 90% stenosed and was located in the non tortuous and moderately calcified left anterior descending artery.

• Brand Name: SYNERGY
• 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: 12752721
• MDR Text Key: 280170815
• Report Number: 2134265-2021-13790
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SF
• 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,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2023
• Device Model Number: 10632
• Device Catalogue Number: 10632
• Device Lot Number: 0027397176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2021
• 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