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

Lot Number 0031052709

Device Problems Break (1069); Difficult to Advance (2920)

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

Event Date 12/04/2023

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely, diffusely calcified right coronary artery (rca).The ostium of the rca was aneurysmal in nature and had an anterio-lateral take-off which made it difficult to find a guide catheter to suitably engage the rca and provide adequate support for the procedure.A 6fr al2 guide catheter was selected which provided sub-optimal support.A rotablation was attempted, however, the guide did not provide adequate support so no rotational atherectomy was performed.A 6fr guidezilla ii was inserted over a non-boston scientific (bsc) guidewire and a 2.75 x 20mm synergy xd was successfully deployed in the mid-rca.A 3.00 x 20mm synergy xd was then advanced for treatment of the proximal rca, however; significant resistance was felt while advancing the synergy xd through the distal third of the distal lumen segment of the guidezilla ii.It was noted that this was caused by the acute angle of the guidezilla as it exited the al2 guide catheter and turned into the ostium of the rca.Advancement of the device required significant force which bent the hypotube outside of the hemostasis valve.The physician attempted to straighten the hypotube, however, it snapped at the point of the kink approximately 110cm from the stent balloon towards the hub of the device outside of the patient's body.The device was removed intact from the patient.The angle of the guidezilla ii and guide catheter was corrected, and the procedure was completed with another of the same device.There was good angiographic result and no patient complications were reported.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).Device evaluated by mfr: synergy xd mr ous 3.00 x 20mm stent delivery system (sds) was returned to the complaint investigation site (cis).A visual, tactile and microscopic examination identified a break was noted at 22cm distal to the distal end of the strain relief along the length of the hypotube shaft.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.A microscopic examination shows there was no sign of damage, stretching or lifting of the stent struts.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.No signs of movement, stent was set between the proximal and distal markerbands.Bumper tip showed no signs of distal tip damage.A device-to-device interaction test shows device could be loaded and tracked over a 0.014" guidewire without issue.

Event Description

It was reported that shaft break occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely, diffusely calcified right coronary artery (rca).The ostium of the rca was aneurysmal in nature and had an anterio-lateral take-off which made it difficult to find a guide catheter to suitably engage the rca and provide adequate support for the procedure.A 6fr al2 guide catheter was selected which provided sub-optimal support.A rotablation was attempted, however, the guide did not provide adequate support so no rotational atherectomy was performed.A 6fr guidezilla ii was inserted over a non-boston scientific (bsc) guidewire and a 2.75 x 20mm synergy xd was successfully deployed in the mid-rca.A 3.00 x 20mm synergy xd was then advanced for treatment of the proximal rca, however; significant resistance was felt while advancing the synergy xd through the distal third of the distal lumen segment of the guidezilla ii.It was noted that this was caused by the acute angle of the guidezilla as it exited the al2 guide catheter and turned into the ostium of the rca.Advancement of the device required significant force which bent the hypotube outside of the hemostasis valve.The physician attempted to straighten the hypotube, however, it snapped at the point of the kink approximately 110cm from the stent balloon towards the hub of the device outside of the patient's body.The device was removed intact from the patient.The angle of the guidezilla ii and guide catheter was corrected, and the procedure was completed with another of the same device.There was good angiographic result and no patient complications were reported.

• 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: 18378238
• MDR Text Key: 331378805
• Report Number: 2124215-2023-69979
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0031052709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• 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