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

Model Number H7493941832300

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 09/30/2022

Event Type  malfunction  

Event Description

It was reported that stent dislodgment occurred.The patient underwent computed tomography (ct) turn down complex multivessel percutaneous coronary intervention.The target lesion was located in the left anterior descending artery.A 3.00 x 32mm synergy xd drug-eluting stent (des) was advanced but failed to cross the lesion.During withdrawal, the stent was dislodged off the balloon in the radial artery and the entire system was pulled from radial access.The patient felt discomfort and pain.Eventually, a 2.5 x 24 synergy xd/ 3.0 x 38 synergy xd and a 4.5 x 16 synergy xd des were used to treat multivessel disease and the procedure was completed with a 3.0 x 38 synergy xd des.The patient was doing well and fully recovered post-procedure.

Event Description

It was reported that stent dislodgment occurred.The patient underwent computed tomography (ct) turn down complex multivessel percutaneous coronary intervention.The target lesion was located in the left anterior descending artery.A 3.00 x 32mm synergy xd drug-eluting stent (des) was advanced but failed to cross the lesion.During withdrawal, the stent was dislodged off the balloon in the radial artery and the entire system was pulled from radial access.The patient felt discomfort and pain.Eventually, a 2.5 x 24 synergy xd/ 3.0 x 38 synergy xd and a 4.5 x 16 synergy xd des were used to treat multivessel disease and the procedure was completed with a 3.0 x 38 synergy xd des.The patient was doing well and fully recovered post-procedure.It was further reported that the target lesion was calcified and tortuous.Additionally, radial access issues were encountered before and after the procedure.

• Brand Name: SYNERGY XD
• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15631616
• MDR Text Key: 303624554
• Report Number: 2124215-2022-41392
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981008
• UDI-Public: 08714729981008
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2023
• Device Model Number: H7493941832300
• Device Lot Number: 0028311656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• 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 Age: 63 YR
• Patient Sex: Female