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

Lot Number 0028834920

Device Problems Device Damaged by Another Device (2915); Device-Device Incompatibility (2919)

Patient Problems Perforation (2001); Foreign Body In Patient (2687)

Event Date 09/06/2022

Event Type  Injury  

Event Description

It was reported that stent damage and vessel perforation occurred.The patient presented for percutaneous coronary intervention (pci).The target lesion was located in the moderately to severely tortuous and moderately calcified left anterior descending (lad) artery.A 3.50 x 32mm synergy xd drug-eluting stent was deployed with a non-boston scientific (bsc) buddy wire jailed behind the stent.Upon removal, the jailed wire got caught with the stent and could not be removed resulting in the stent being deformed and the wire tip fracturing.The stent was then crushed against the fractured wire tip with another synergy xd drug-eluting stent deployed.However, a distal wire perforation occurred in the lad that was then resolved with coiling.No further complications were reported.

• 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: 15510568
• MDR Text Key: 300875854
• Report Number: 2124215-2022-35051
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Lot Number: 0028834920
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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
• Treatment: GUIDEWIRE: SION BLUE
• Patient Outcome(s): Other; Required Intervention