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

Model Number	H7493942808400
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered.The 65% stenosed target lesion was located in the moderately tortuous and calcified left main/circumflex artery.After a non-boston scientific (bsc) guidewire crossed the lesion and a 7f non-bsc guide catheter was engaged, pre-dilatation was performed using a 2.5mm non-bsc balloon catheter followed by a 3.5mm wolverine cutting balloon.A 3.50 x 28mm synergy megatron was advanced for treatment.The stent was placed at 18 atmospheres and well positioned; however, stent shortening was observed under angiography.A 4.00 x 8mm synergy megatron was then advanced and placed proximal to the first stent.After deflating the stent balloon for a deliberately long time, the balloon still hung up and was difficult to remove from the stent.The balloon had difficulty coming back in the guide catheter and the guide catheter tip became damaged.Attempts were made to deflate the balloon further and eventually the partially inflated balloon was pulled out intact.Post-dilatation was performed with a 4.00 x 8mm nc emerge balloon and the procedure completed.No patient complications were reported.
Event or Problem Description
It was reported that removal difficulties were encountered.The 65% stenosed target lesion was located in the moderately tortuous and calcified left main/circumflex artery.After a non-boston scientific (bsc) guidewire crossed the lesion and a 7f non-bsc guide catheter was engaged, pre-dilatation was performed using a 2.5mm non-bsc balloon catheter followed by a 3.5mm wolverine cutting balloon.A 3.50 x 28mm synergy megatron was advanced for treatment.The stent was placed at 18 atmospheres and well positioned; however, stent shortening was observed under angiography.A 4.00 x 8mm synergy megatron was then advanced and placed proximal to the first stent.After deflating the stent balloon for a deliberately long time, the balloon still hung up and was difficult to remove from the stent.The balloon had difficulty coming back in the guide catheter and the guide catheter tip became damaged.Attempts were made to deflate the balloon further and eventually the partially inflated balloon was pulled out intact.Post-dilatation was performed with a 4.00 x 8mm nc emerge balloon and the procedure completed.No patient complications were reported.It was further reported that there was no foreshortening noted with a 3.50 x 28mm synergy megatron stent.The 28mm length was not long enough and the stent was well positioned, apposed, fully expanded and it was successfully implanted.
Additional Manufacturer Narrative
The synergy megatron mr us 4.00 x 8mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found that the stent was not returned as it was implanted during the procedure.The balloon cones were reviewed via scope, and distal balloon bunching was noted.It appeared that the balloon had been subjected to pressure.A visual and tactile examination of the hypotube found multiple kinks.Examination of the tip via scope found no damage to the tip.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and a tactile examination was performed.No damage was noted.A recommended 0.014 guidewire was introduced into the device without issue.The sds was advanced through a test 7f guide catheter without issue.As the device was inside the 7f test guide catheter the balloon was inflated to rated burst pressure without issue, maintained pressure, and deflated without issue and a vacuum was pulled on the device for 40 seconds (greater than 30seconds as per instructions for use).No damage was noted on the balloon or device during functional testing, and the sds was removed proximally from the 7f guide catheter without issue.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that removal difficulties were encountered.The 65% stenosed target lesion was located in the moderately tortuous and calcified left main/circumflex artery.After a non-boston scientific (bsc) guidewire crossed the lesion and a 7f non-bsc guide catheter was engaged, pre-dilatation was performed using a 2.5mm non-bsc balloon catheter followed by a 3.5mm wolverine cutting balloon.A 3.50 x 28mm synergy megatron was advanced for treatment.The stent was placed at 18 atmospheres and well positioned; however, stent shortening was observed under angiography.A 4.00 x 8mm synergy megatron was then advanced and placed proximal to the first stent.After deflating the stent balloon for a deliberately long time, the balloon still hung up and was difficult to remove from the stent.The balloon had difficulty coming back in the guide catheter and the guide catheter tip became damaged.Attempts were made to deflate the balloon further and eventually the partially inflated balloon was pulled out intact.Post-dilatation was performed with a 4.00 x 8mm nc emerge balloon and the procedure completed.No patient complications were reported.It was further reported that there was no foreshortening noted with a 3.50 x 28mm synergy megatron stent.The 28mm length was not long enough and the stent was well positioned, apposed, fully expanded and it was successfully implanted.

• Brand Name: SYNERGY MEGATRON
• Common Device Name: 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: 15642217
• Report Number: 2124215-2022-41722
• Device Sequence Number: 6444668
• Product Code: NIQ
• UDI-Device Identifier: 08714729985549
• UDI-Public: 08714729985549
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2023
• Device Model Number: H7493942808400
• Device Lot Number: 0028675593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 11/07/2022; 11/29/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 11/17/2022; 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: MEDTRONIC 7F EBU 3.5 GUIDE; GUIDE CATHETER: MEDTRONIC 7F EBU 3.5 GUIDE; GUIDE CATHETER: MEDTRONIC 7F EBU 3.5 GUIDE; GUIDE WIRE: ASAHI SION; GUIDE WIRE: ASAHI SION; GUIDE WIRE: ASAHI SION
• Patient Sex: Unknown