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

Model Number H7493941848350

Device Problems Break (1069); Deflation Problem (1149); Difficult to Remove (1528)

Patient Problems Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 05/04/2021

Event Type  Injury  

Event Description

It was reported via medwatch balloon deflation failure occurred.The target lesion was located from the mid left anterior descending artery (lad) all the way back to the left main (lm).Following rotoblating and ballooning, a 3.50 x 48mm synergy xd drug-eluting stent was advanced for treatment and inflated at 12 atm.However, after deflation, the balloon would not come out.The balloon was re-inflated to 20 atm but still would not move.The balloon was reinflated a third time and appeared to rupture as the inflation device would not hold pressure, but the balloon did not deflate.The patient was getting hypotensive so the physician pulled harder and the balloon shaft broke leaving behind an inflated balloon which was occluding flow in the lm and lad.The physician then took a non-boston scientific (bsc) guidewire to try to perforate the balloon but failed.They attempted to remove the device with snares but this was also unsuccessful.A non-bsc 3.00mm x 31mm balloon catheter was used to crush the first stent and balloon out of the way, restoring flow in the lad.A 3.00x31mm synergy xd stent was then used to re-stent the lesion and pin the retained balloon and stent to the vessel wall.After pinning with stents, the contrast in the lad portion of the retained balloon was forced back into the aortic portion.There is now a contrast filled portion of the stent balloon extending from the lm ostium back into the aorta about 10-15mm, touching but does not interfering with the aortic valve function at this point in time.It was noted that the patient required endotracheal intubation and heavy sedation.No further patient complications were reported, and the patient was discharged after a prolonged admission.It was recommended the patient return for a repeat computed tomographic angiography (cta) and echo in three months.

Event Description

It was reported via medwatch balloon deflation failure occurred.The target lesion was located from the mid left anterior descending artery (lad) all the way back to the left main (lm).Following rotoblating and ballooning, a 3.50 x 48mm synergy xd drug-eluting stent was advanced for treatment and inflated at 12 atm.However, after deflation, the balloon would not come out.The balloon was re-inflated to 20 atm but still would not move.The balloon was reinflated a third time and appeared to rupture as the inflation device would not hold pressure, but the balloon did not deflate.The patient was getting hypotensive so the physician pulled harder and the balloon shaft broke leaving behind an inflated balloon which was occluding flow in the lm and lad.The physician then took a non-boston scientific (bsc) guidewire to try to perforate the balloon but failed.They attempted to remove the device with snares but this was also unsuccessful.A non-bsc 3.00mm x 31mm balloon catheter was used to crush the first stent and balloon out of the way, restoring flow in the lad.A 3.00x31mm synergy xd stent was then used to re-stent the lesion and pin the retained balloon and stent to the vessel wall.After pinning with stents, the contrast in the lad portion of the retained balloon was forced back into the aortic portion.There is now a contrast filled portion of the stent balloon extending from the lm ostium back into the aorta about 10-15mm, touching but does not interfering with the aortic valve function at this point in time.It was noted that the patient required endotracheal intubation and heavy sedation.No further patient complications were reported, and the patient was discharged after a prolonged admission.It was recommended the patient return for a repeat computed tomographic angiography (cta) and echo in three months.

Manufacturer Narrative

The synergy xd mr us 3.50 x 48mm stent delivery system (sds) was returned for analysis without the distal shaft, balloon or stent.A visual and tactile examination found multiple kinks along the hypotube.A visual and tactile examination of the outer lumen and mid-shaft section found a shaft break in the midshaft region of the shaft polymer extrusion measured at approximately 118cm distal to the distal end of the strain relief with the core wire exposed.No other issues were identified during the product analysis.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11881535
• MDR Text Key: 253213668
• Report Number: 2134265-2021-06708
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729985235
• UDI-Public: 08714729985235
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

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: 11/09/2022
• Device Model Number: H7493941848350
• Device Lot Number: 0026373118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 08/18/2021
• Supplement Dates FDA Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR