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

Lot Number 30793686

Patient Problem Pain (1994)

Event Date 11/28/2023

Event Type  malfunction  

Event Description

Regarding placement of synergy xd stent.Three separate attempts were required before a stent "hooked".The first two attempts were failures and each had to be removed (pulled out).A new stent was used for the second attempt and it too failed and had to be removed.The third attempt was successful.The pain from removing the two stents excruciating.I was not sedated appropriately for these adverse proceedings.Not the fault of the physician.Ref report: mw5148827.

• Brand Name: SYNERGY XD CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 18273865
• MDR Text Key: 330014022
• Report Number: MW5148826
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 30793686
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White