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

Model Number	H7493942816450
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a shaft break occurred.A percutaneous coronary intervention was performed on a calcified proximal right coronary artery (rca).A 4.50 x 16mm synergy megatron was advanced through an 8f convey guide catheter, and was deployed in the proximal rca.Following deployment, the balloon was fully deflated and there was an attempt to remove the delivery system, but it had become stuck in the guide catheter.The stent delivery system was stuck in the convey after the stent was deployed.In an attempt to dislodge the balloon, a buddy wire was advanced, the physician cut the shaft of the stent catheter by the back of the hub, and placed a guidezillla over the cut stent shaft to attempt to sheath the balloon, but was unsuccessful.Everything was removed together from the patient.A new 8 f convery guide catheter and megatron stent were used to complete the procedure without issues.The second megatron stent had been deployed due to the first megatron had missed the ostium portion of the artery, and a second stent was needed to cover the entire lesion.It was noted that at the start of the case, a rotapro atherectomy was performed.A 2.0 burr was used to treat the ostial lesion, but when removing the products from the patient, it was noticed that the tip of the convey guide catheter was damaged.No patient complications resulted in relation to this event, and the patient was reported to be fine following the procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: synergy megatron mr us 4.50 x 16mm stent delivery system (sds), was returned for analysis on the customer guidewire measured at 0.0140 and inside the customer 8f guidecatheter, the following attributes were examined: stent profile: no stent was returned as the stent was implanted in the patient.Balloon profile: the delivery system was pushed distally indie the guidecatheter and the balloon exited though the distal end of the guide.The balloon cones were reviewed and were noted to be bunched in the distal region.The proximal markerband was noted to be located at the proximal balloon bond suggesting stretching of the inner shaft polymer extrusion.Traces of dried blood like substance were noted inside the balloon cones and inflation lumen.Tip profile: a visual and microscopic examination of the bumper tip showed no signs of tip damage.Hypotube profile: a visual and tactile examination of the hypotube shaft found that the haft was broken with a section of the hypotube 40.5 cm outside the proximal end of the guide.A section of the hypotube was missing along with the manifold hub.Shaft polymer extrusion profile: a visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.However as the proximal stent markerband was noted to be shifted in position distally this indicates that an inner haft stretching has occurred.Functional analysis: the device was soaked for several days in a waterbath and an inflation attempt was made where an inflation aid was attached to the broken section of the hypotube shaft however the balloon would not inflate due to residue present in the inflation lumen.No leaks were noted from the balloon or shaft and the inflation device was maintaining pressure.The inflation device was verified before and after the inflation using a druck gauge.Guide catheter assessment: the tip of the guidecatheter was noted to be torn.No other issues were identified during analysis.
Event or Problem Description
It was reported that a shaft break occurred.A percutaneous coronary intervention was performed on a calcified proximal right coronary artery (rca).A 4.50 x 16mm synergy megatron was advanced through an 8f convey guide catheter, and was deployed in the proximal rca.Following deployment, the balloon was fully deflated and there was an attempt to remove the delivery system, but it had become stuck in the guide catheter.The stent delivery system was stuck in the convey after the stent was deployed.In an attempt to dislodge the balloon, a buddy wire was advanced, the physician cut the shaft of the stent catheter by the back of the hub, and placed a guidezillla over the cut stent shaft to attempt to sheath the balloon, but was unsuccessful.Everything was removed together from the patient.A new 8 f convery guide catheter and megatron stent were used to complete the procedure without issues.The second megatron stent had been deployed due to the first megatron had missed the ostium portion of the artery, and a second stent was needed to cover the entire lesion.It was noted that at the start of the case, a rotapro atherectomy was performed.A 2.0 burr was used to treat the ostial lesion, but when removing the products from the patient, it was noticed that the tip of the convey guide catheter was damaged.No patient complications resulted in relation to this event, and the patient was reported to be fine following the procedure.
Event or Problem Description
It was reported that the shaft was cut.A percutaneous coronary intervention was performed on a calcified proximal right coronary artery (rca).A 4.50 x 16mm synergy megatron was advanced through an 8f convey guide catheter, and was deployed in the proximal rca.Following deployment, the balloon was fully deflated and there was an attempt to remove the delivery system, but it had become stuck in the guide catheter.The stent delivery system was stuck in the convey after the stent was deployed.In an attempt to dislodge the balloon, a buddy wire was advanced, the physician cut the shaft of the stent catheter by the back of the hub, and placed a guidezillla over the cut stent shaft to attempt to sheath the balloon, but was unsuccessful.Everything was removed together from the patient.A new 8 f convery guide catheter and megatron stent were used to complete the procedure without issues.The second megatron stent had been deployed due to the first megatron had missed the ostium portion of the artery, and a second stent was needed to cover the entire lesion.It was noted that at the start of the case, a rotapro atherectomy was performed.A 2.0 burr was used to treat the ostial lesion, but when removing the products from the patient, it was noticed that the tip of the convey guide catheter was damaged.No patient complications resulted in relation to this event, and the patient was reported to be fine following the procedure.
Additional Manufacturer Narrative
Correction to b5: clarification that the stent was manually cut, not broken.Correction to h6: device code of "break" removed as stent was manually cut not broken.Correction to h6: evaluation result code of "fracture problem" removed as stent was manually cut not broken.Device evaluated by manufacturer: synergy megatron mr us 4.50 x 16mm stent delivery system (sds), was returned for analysis on the customer guidewire measured at 0.0140 and inside the customer 8f guidecatheter, the following attributes were examined: stent profile: no stent was returned as the stent was implanted in the patient.Balloon profile: the delivery system was pushed distally indie the guidecatheter and the balloon exited though the distal end of the guide.The balloon cones were reviewed and were noted to be bunched in the distal region.The proximal markerband was noted to be located at the proximal balloon bond suggesting stretching of the inner shaft polymer extrusion.Traces of dried blood like substance were noted inside the balloon cones and inflation lumen.Tip profile: a visual and microscopic examination of the bumper tip showed no signs of tip damage.Hypotube profile: a visual and tactile examination of the hypotube shaft found that the shaft was broken with a section of the hypotube 40.5 cm outside the proximal end of the guide.A section of the hypotube was missing along with the manifold hub.Shaft polymer extrusion profile: a visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.However as the proximal stent markerband was noted to be shifted in position distally, this indicates that an inner shaft stretching had occurred.Functional analysis: the device was soaked for several days in a waterbath and an inflation attempt was made where an inflation aid was attached to the broken section of the hypotube shaft however the balloon would not inflate due to residue present in the inflation lumen.No leaks were noted from the balloon or shaft and the inflation device was maintaining pressure.The inflation device was verified before and after the inflation using a druck gauge.Guide catheter assessment: the tip of the guidecatheter was noted to be torn.No other issues were identified during analysis.

• 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: 14251442
• Report Number: 2134265-2022-04978
• Device Sequence Number: 4887571
• Product Code: NIQ
• UDI-Device Identifier: 08714729985631
• UDI-Public: 08714729985631
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/01/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2022
• Device Model Number: H7493942816450
• Device Lot Number: 0027578235
• 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: 04/08/2022
• Supplement Date Received by Manufacturer: 06/10/2022; 10/25/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 06/17/2022; 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown