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

Model Number 10621

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2020

Event Type  malfunction  

Event Description

It was reported that stent was difficult to view under fluoroscopy.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 3.50 x 28 synergy drug-eluting stent was advanced for treatment.However, during deployment, the physician was unable to clearly see the stent struts under fluoroscopy making it difficult to find good stent placement before inflation of the stent within the vessel.The stent was deployed without any issues.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that stent was difficult to view under fluoroscopy.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 3.50 x 28 synergy drug-eluting stent was advanced for treatment.However, during deployment, the physician was unable to clearly see the stent struts under fluoroscopy making it difficult to find good stent placement before inflation of the stent within the vessel.The stent was deployed without any issues.No patient complications were reported and the patient's status was stable.It was further reported that no poor visibility due to a fault on the stent's part occurred.The physician used another drug-eluting stent as a point of comparison to determine if it is a synergy problem or if it could be a more technical issue related to the equipment and or the radiation.The physician decided to use a non-bsc stent and when he delivered and expanded the stent, it was clear that the non-bsc stent too was not visibly clear under fluoroscopy giving all present a reason to believe that the issue is due to a possible equipment or radiation fault.

Event Description

It was reported that stent was difficult to view under fluoroscopy.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 3.50 x 28 synergy drug-eluting stent was advanced for treatment.However, during deployment, the physician was unable to clearly see the stent struts under fluoroscopy making it difficult to find good stent placement before inflation of the stent within the vessel.The stent was deployed without any issues.No patient complications were reported and the patient's status was stable.It was further reported that no poor visibility due to a fault on the stent's part occurred.The physician used another drug-eluting stent as a point of comparison to determine if it is a synergy problem or if it could be a more technical issue related to the equipment and or the radiation.The physician decided to use a non-bsc stent and when he delivered and expanded the stent, it was clear that the non-bsc stent too was not visibly clear under fluoroscopy giving all present a reason to believe that the issue is due to a possible equipment or radiation fault.It was further reported that the previously reported issue was not for 3.50 x 28 synergy drug-eluting stent.

Manufacturer Narrative

F10: device code update from material integrity problem to adverse event without identified device or use problem.B5: describe event or problem updated.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10869377
• MDR Text Key: 217168187
• Report Number: 2134265-2020-16031
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2021

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: 06/29/2022
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0025682037
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 12/02/2020; 01/20/2021
• Supplement Dates FDA Received: 12/15/2020; 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1