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

Model Number 10621

Device Problem Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent damage occurred.The target lesion was located in the mildly tortuous and mildly calcified left main artery (lm) and proximal left anterior descending artery (lad).After pre-dilatation was performed, a 30x38mm synergy drug-eluting stent (des) was deployed in the lad and a 4.00x28mm synergy des was implanted for treatment in the lm.After the procedure, the physician checked by intravascular ultrasound and it was noted that the 4.00 x 28 synergy drug-eluting stent did not completely cover the lesion in the lm.The physician thought that the stent struts had stretched so the lesion was not covered completely.One more 4.0x16mm synergy des was implanted inside the 4.0x28mm stent to complete the procedure.No patient complications nor injuries were reported.

Event Description

It was reported that stent damage occurred.The target lesion was located in the mildly tortuous and mildly calcified left main artery (lm) and proximal left anterior descending artery (lad).After pre-dilatation was performed, a 30x38mm synergy drug-eluting stent (des) was deployed in the lad and a 4.00x28mm synergy des was implanted for treatment in the lm.After the procedure, the physician checked by intravascular ultrasound and it was noted that the 4.00 x 28 synergy drug-eluting stent did not completely cover the lesion in the lm.The physician thought that the stent struts had stretched so the lesion was not covered completely.One more 4.0x16mm synergy des was implanted inside the 4.0x28mm stent to complete the procedure.No patient complications nor injuries were reported.It was further reported that the lm stent was post dilated with a 4.00x10mm nc balloon.

Manufacturer Narrative

A review of the media provided identified the alleged stent material deformation.Gaps can be noted in the mid to proximal region of the left main (lm) deployed stent.As the stent damage was not apparent immediately post deployment and it was only visible following post dilation and after the stent was crossed two times by a guidewire from and to the left circumflex artery, it is most likely that a combination of procedural factors including a possible overexpansion of the proximal lm region of the stent as well as interaction with ancillary devices caused the alleged stent material deformation.

• 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: 10241051
• MDR Text Key: 197818164
• Report Number: 2134265-2020-08337
• 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
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2021
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0024699924
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR