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

Device Problems Fracture (1260); Device Damaged by Another Device (2915); Activation Failure (3270)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/02/2023

Event Type  Injury  

Event Description

It was reported that stent fracture and damage post-deployment occurred requiring intervention.The patient presented with coronary artery disease (cad).Percutaneous coronary intervention (pci) was performed.Following pre-dilation, a 4.00 x 16mm synergy xd drug-eluting stent was deployed in ostial right coronary artery.The stent delivery system was then removed, and angioplasty was performed.During the angioplasty, it was observed that the proximal stent was in question of expansion, and it was decided to perform an intravascular ultrasound (ivus) using non-boston scientific (bsc) device.Under ivus, it was noted that the stent had not fully expanded.A 4.5x12 nc quantum apex was then placed and would not expand the stent either, so the physician decided to use a shockwave with a 4.0x12 sw balloon.Upon inflation and delivery of the shocks, it was noted that the stent had a malformation.The shockwave balloon was removed, and the proximal edge part of the stent with the crown was snapped in half.The stent remained in the patient and was scheduled for open heart surgery to retrieve the broken part of the stent.The patient was stable post-procedure and is expected to fully recover.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18182206
• MDR Text Key: 328673185
• Report Number: 2124215-2023-65139
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981121
• UDI-Public: 08714729981121
• 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
• Report Date: 11/21/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Sex: Female