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

Model Number H7493941832400

Device Problem Material Frayed (1262)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2022

Event Type  malfunction  

Event Description

Patient was brought to cardiac cath lab, prepped and draped in sterile fashion.Procedure went as planned: angiography with runoff, and balloon angioplasty.Findings included occlusion of the femoral below-knee popliteal /tp trunk synthetic graft in its mid segment, which was previously stented, thrombus noted at the distal anastomosis to the tp trunk that was also previously stented.The team decided to proceed with percutaneous intervention of the bypass graft and distal graft-tp trunk anastomosis.When it was time to use the drug-eluting stent, they found the stent partially expanded and severely frayed from the package.It was then taken out of use and exchanged for another one.The procedure went on and was completed with no harm done to the patient.Manufacturer response for coronary drug-eluting stent, synergy¿ xd (per site reporter).Cath lab manager spoke to representative after device was taken out of use.

• 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: 13994270
• MDR Text Key: 288490847
• Report Number: 13994270
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981169
• UDI-Public: (01)08714729981169(17)230118(10)26702077
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2022,03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493941832400
• Device Lot Number: 26702077
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Race: White