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

Model Number 10618

Device Problem Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent migration occurred.A percutaneous coronary intervention was being performed on a 90% stenosed and severely calcified lesion in the ramus inter ventricularis anterior (riva) in the left coronary artery.The balloon of the 2.50 x 12 mm synergy ii des could not be inflated due to a perforation.A 2.25 x 16 mm synergy stent was implanted and post dilated with a 3.0 x 20 mm balloon which caused the 2.25 x 16 mm synergy stent to migrate a bit.A second 2.5 x 12 mm balloon was used for post-dilating for 12 seconds with a good result.A long plaque was detected in the riva, which was treated with two additional stents.The second stent was a 2.5 x 24 mm synergy in the riva which overlapped with a third 3.0 x 16 mm synergy stent.The riva procedure was successfully completed with implantation of three synergy stents.

• 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9161105
• MDR Text Key: 161423945
• Report Number: 2134265-2019-11709
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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