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

Model Number 10616

Device Problem Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent migration occurred.The 75% stenosed target lesion was located in the severely tortuous and severely calcified left main (lm) artery.Following pre-dilation, a 4.00 x 8mm synergy drug-eluting stent was implanted in the lm.However, it was noted that the stent migrated and was found at the common iliac artery.The migrated device was removed by snaring and they completed the procedure with a different device.No complications were reported and the patient condition was fine.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8135818
• MDR Text Key: 129434561
• Report Number: 2134265-2018-63543
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2019
• Device Model Number: 10616
• Device Catalogue Number: 10616
• Device Lot Number: 0021869864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2018
• 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