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

Model Number H7493941812400

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906); Pressure Problem (3012)

Patient Problem Insufficient Information (4580)

Event Date 05/21/2021

Event Type  Injury  

Event Description

A 4.0 x 48 mm stent was carefully positioned in between the two stents that had been implanted in 2017.After multiple fluoroscopy confirmation, the stent was deployed and post-dilated with a 4.0 x 20 mm balloon that was sequentially inflated within the stent up to 20 atmospheric pressure.Completion angiogram showed that there was an intervening segment between the distal and the freshly deployed stent.A 4.0 x 12 mm synergy drug-eluting stent was carefully positioned, and was attempted to be deployed, but unfortunately it would not go up to the nominal pressure.In fact, there was a loss of pressure during stent deployment from 4 to 5 atmospheric pressure.Repeated attempts did not deploy the stent.There was a partially inflated balloon in the stented segment.Attempts to get negative suction failed to retrieve all the contrast.It was decided to retrieve the delivery system, and on gentle retrieval it was noted that the stent shaft has broken into the left anterior descending arterial system.The patient was transferred to the or for an emergent lima lad life-saving coronary artery bypass procedure with transcoronary retrieval of the broken stent.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11974088
• MDR Text Key: 255363812
• Report Number: 11974088
• 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: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493941812400
• Device Catalogue Number: H7493941812400
• Device Lot Number: 26345138
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 13140 DA
• Patient Weight: 148