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

Model Number H7493926020350

Device Problem Break (1069)

Patient Problems Myocardial Infarction (1969); Stenosis (2263)

Event Date 07/01/2019

Event Type  malfunction  

Event Description

The ostium of the right coronary artery was very difficult to cannulate secondary to severe ostial stenosis and a takeoff of multiple branches early in the vessel.In order to ensure access to the vessel, we anchored a guidewire in one of these branches and the guidewire could not be pulled out in its entirety when removed.Because of the presence of a stent at that site, the tip of the wire broke leaving the tip in the proximal right coronary artery.This, however, was excluded from the lumen with 2 layers of drug-eluting stent with final timi (thrombolysis in myocardial infarction) grade iii flow.To clarify, patient had first stent placed as intended, then the tip of the guidewire broke.The provider was aware of the retained guidewire tip and elected to place a second stent in order to anchor and secure the retained tip in between the 2 stents.

• 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: 8925506
• MDR Text Key: 155355505
• Report Number: 8925506
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493926020350
• Device Catalogue Number: H7493926020350
• Device Lot Number: 23736850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20075 DA
• Patient Weight: 99