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

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Failure to Deflate (4060)

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

Event Date 06/30/2023

Event Type  Injury  

Event Description

It was reported that deflation issues, removal difficulties, and device detachment occurred.The 90% stenosed, long target lesion was located in the severely tortuous and severely calcified circumflex artery.Shockwave was used to treat the lesion prior to stent implantation.A 4.00 x 38mm synergy xd drug-eluting stent was inserted and deployed at 12 atmospheres for 10 seconds; it was noted that inflation was hard to see due to the heavily calcified lesion.The balloon of the stent delivery system (sds) was then deflated, and when the physician pulled back on the sds some resistance was encountered.The physician continued to pull and when the device was outside the patient, it was noticed that the balloon was detached from the sds.It appeared that the balloon had not fully deflated and became caught in an under expanded proximal portion of the lesion during removal.Multiple unsuccessful attempts were made to snare and puncture the balloon.Consequently, open heart surgery was performed to remove the remaining balloon components from the patient.The patient fully recovered and was discharged.

• 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: 17397233
• MDR Text Key: 319834011
• Report Number: 2124215-2023-37263
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2023

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: 07/04/2023
• Initial Date FDA Received: 07/26/2023
• 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