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

Lot Number 0025652592

Device Problem Obstruction of Flow (2423)

Patient Problems Reocclusion (1985); Restenosis (4576)

Event Date 01/12/2021

Event Type  Injury  

Event Description

It was reported that occlusion occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery (lad) first diagonal.A 2.25 x 24mm synergy xd drug eluting stent was placed in the vessel on january 05, 2021.However, during follow up angiography after one week, the location where the device was placed was found to be occluded.There were no chest pain experienced by the patient.The procedure was completed by placing a 0.014 wire, and then nipro colofrex was placed on top of the occluded part of the device.There was no patient injury reported.

Event Description

It was reported that occlusion occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery (lad) first diagonal.A 2.25 x 24mm synergy xd drug eluting stent was placed in the vessel on (b)(6) 2021.However, during follow up angiography after one week, the location where the device was placed was found to be occluded.There were no chest pain experienced by the patient.The procedure was completed by placing a 0.014 wire, and then nipro colofrex was placed on top of the occluded part of the device.There was no patient injury reported.It was further reported that the physician reviewed the contrast image and ivus image again.It was determined that the occlusion was not thrombosis and occurred due to other reason.It was further reported that only the 2.25x24mm synergy stent was deployed in the first diagonal branch.According to the ivus, the stent was well pressed on the vessel wall so it is unlikely that it originated from the stent.

Manufacturer Narrative

B1 adverse event/product problem and b3 date of event corrected.

Manufacturer Narrative

B1: adverse event/product problem.B3: date of event corrected.

Event Description

It was reported that occlusion occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery (lad) first diagonal.A 2.25 x 24mm synergy xd drug eluting stent was placed in the vessel on (b)(6) 2021.However, during follow up angiography after one week, the location where the device was placed was found to be occluded.There were no chest pain experienced by the patient.The procedure was completed by placing a 0.014 wire, and then nipro colofrex was placed on top of the occluded part of the device.There was no patient injury reported.It was further reported that the physician reviewed the contrast image and ivus image again.It was determined that the occlusion was not thrombosis and occurred due to other reason.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11238392
• MDR Text Key: 228966983
• Report Number: 2134265-2021-00433
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2022
• Device Lot Number: 0025652592
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention