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

Lot Number 0026609004

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problems Hematoma (1884); Pericardial Effusion (3271)

Event Date 09/06/2021

Event Type  Injury  

Event Description

It was reported that stent damage, hematoma, and pericardial effusion occurred. The 70-80% stenosed target lesion was located in the left anterior descending artery (lad) before the first diagonal. A 3. 00 x 12mm synergy xd was implanted and post dilated with a 3. 50 x 8mm nc emerge at 14 atmospheres. Post stenting optical coherence tomography imaging showed the stent had proximal edge strut malapposition. The physician decided to post-dilate with a 3. 5mm x 8mm nc emerge balloon catheter from 16-20 atmospheres. However, during inflation at 18 atmospheres, the balloon ruptured and was removed. The physician suspected there was a perforation but an angiogram revealed a large intramural hematoma from the proximal lad to the left main artery. They proceeded with an urgent echocardiogram which showed no pericardial effusion. After 20 minutes, a repeat catheterization and ivus showed hematoma. There is no dissection and the hematoma size had been reduced. A repeat echo showed effusion but the patient activated clotting time was normal (above 350). The physician send the patient for ct aortogram & observation. No further complications were reported and the patient was stable.

• 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: 12490581
• MDR Text Key: 271983371
• Report Number: 2134265-2021-11783
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Lot Number: 0026609004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/17/2021 Patient Sequence Number: 1