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

Model Number 10617

Device Problem Defective Device (2588)

Patient Problems Prolapse (2475); No Code Available (3191)

Event Date 08/28/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that tissue / plaque prolapse occurred.A percutaneous coronary intervention was being performed on a lesion in the left main coronary artery.The lesion was predilated with 2.5 mm balloon and then further predilated with a 3.0 mm scoring balloon.A 4 mm x 12 mm synergy stent was then deployed at 12 atmospheres.Immediately after stent deployment, an abnormality in the middle of the stent was angiographically seen and seemed a plaque prolapse occurred.The synergy stent was post dilated with 4.0 mm nc balloon at 15 atmospheres.After the post-dilatation it was observed angiographically that the in-stent abnormality had increased many folds.A 4 mm non-bsc drug eluding stent was then implanted.Per the user, it may have been a case of distortion of the stent struts or stent fracture, however this is not known.The patient was successfully discharged.

• Brand Name: SYNERGY
• 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: 9119325
• MDR Text Key: 160154308
• Report Number: 2134265-2019-11522
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2019
• Device Model Number: 10617
• Device Catalogue Number: 10617
• Device Lot Number: 0022162878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR