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

Model Number 10616

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent fracture occurred.The 80% stenosed target lesion was located in the middle left anterior descending artery.A 4.00 x 8 synergy drug-eluting stent was advanced for treatment.However, during inflation of the 5.5x8 nc balloon at 12 atmospheres, it was noticed that the stent was fractured.Another stent was implanted overlapping the synergy stent.There were no patient complications reported and the patient's status was stable.

Manufacturer Narrative

Device is a combination product.Five still images from the angiographic procedure were received from the site.The provided images from the angiographic series were not consistent with the reported event of stent fracture.A 4.00 x 8 synergy drug-eluting stent was advanced for treatment and deployed at a lesion site in mid lad.The lesions site coincided with a bifurcation region and several constriction regions are noted in the second image when an inflated post dilation balloon is shown.In the third still image stent damage is noted in the form of displaced struts coinciding with one of the constriction regions noted previously in the mid stent region and suggesting the presence of a fibrocalcific lesion.The 4th still image shows views of the lesion site under contrast flow with the fifth and final image showing a very faint outline of an expanded stent with a constriction region still noticeable in the same area where the displaced struts were previously noted.The presence of the constriction regions, recorded at the same locations as during balloon dilations stages, confirms the likely presence of calcific nodules in the treated lesion.These nodules induce a conformation of the stent to the calcific nodules and provide the misleading conclusion that there is a fracture in the deployed stent.

Event Description

It was reported that stent fracture occurred.The 80% stenosed target lesion was located in the middle left anterior descending artery.A 4.00 x 8 synergy drug-eluting stent was advanced for treatment.However, during inflation of the 5.5x8 nc balloon at 12 atmospheres, it was noticed that the stent was fractured.Another stent was implanted overlapping the synergy stent.There were no patient complications reported and the patient's status was stable.

• 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: 9416725
• MDR Text Key: 169255741
• Report Number: 2134265-2019-14880
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2019
• Device Model Number: 10616
• Device Catalogue Number: 10616
• Device Lot Number: 0022224904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR