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

Lot Number 0028630801

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)

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

Event Date 08/19/2022

Event Type  Injury  

Event Description

It was reported that shaft break and surgical intervention occurred.The target lesion was located in the ostium of the right coronary artery.A 4.5mm x 12mm synergy megatron drug-eluting stent was implanted successfully at nominal pressures.Ostial flaring of the stent was then performed at 16atm.Upon withdrawal, the shaft was very snug/tight on the wire and not moving.The stent balloon was approximately 80% outside of the guide and could not be withdrawn any further.With gentle manipulation to get the balloon free from the wire, the shaft became free, however, it had detached/broken off of the balloon.An attempt to remove the whole system (balloon + wire) out as one unit was successful up to the brachial artery region, where the balloon came off the wire and was hanging free in the brachial artery.Removal attempts were unsuccessful and the patient required invasive surgery to remove the device fragment.The stent procedure was completed successfully.The patient is doing well with no further patient complications reported.

Event Description

It was reported that shaft break and surgical intervention occurred.The target lesion was located in the ostium of the right coronary artery.A 4.5mm x 12mm synergy megatron drug-eluting stent was implanted successfully at nominal pressures.Ostial flaring of the stent was then performed at 16atm.Upon withdrawal, the shaft was very snug/tight on the wire and not moving.The stent balloon was approximately 80% outside of the guide and could not be withdrawn any further.With gentle manipulation to get the balloon free from the wire, the shaft became free, however, it had detached/broken off of the balloon.An attempt to remove the whole system (balloon + wire) out as one unit was successful up to the brachial artery region, where the balloon came off the wire and was hanging free in the brachial artery.Removal attempts were unsuccessful and the patient required invasive surgery to remove the device fragment.The stent procedure was completed successfully.The patient is doing well with no further patient complications reported.It was further reported that resistance was met in withdrawing the stent balloon from vessel to guide, after deploying the stent.It moved very little and only came back about 20% into the guide.Before pulling back the device, the physician waited long enough for the balloon to be fully deflated with no contrast in it on fluoroscopy.It was noted that it was a large 4.5 balloon, and that the physician waited anywhere up to 10 seconds prior to removing the balloon.Absence of contrast was confirmed within the balloon under fluoroscopy.No further patient complications were reported in relation to this event.It was further reported that the initial deflation time was 15 seconds and there was no contrast visible in balloon.Then, the physician did an extra 2 deflations and overall deflation time would have been in excess of 30 seconds.

Manufacturer Narrative

Device evaluated by mfr.: (media review) the complaint device was not received for analysis however seventeen angiographic images were received and reviewed.A guide catheter was in position at the rca ostium with a guidewire through the artery.A non-bsc stent is noted to be positioned and deployed in prox to mid rca.A bsc stent is then positioned and deployed in ostial to proximal rca overlapping the previous non bsc deployed stent.Post-dilation of the megatron stent and of the non-bsc stent overlapped region is noted.No attempt to withdraw the delivery system from rca is noted.Markerbands corresponding to the stent delivery system balloon are noted in the brachial artery.This suggests the delivery balloon was detached from the delivery system.Unsuccessful attempts to remove the balloon with a snare are noted in the last few series.A review of the media provided could identify the alleged balloon detachment, as the images provided showed a delivery system balloon loose in the brachial artery and its removal was attempted via a snare.No withdrawal attempts of the stent delivery system from the deployed megatron stent were noted in the images provided.H3 other text : media.

Event Description

It was reported that shaft break and surgical intervention occurred.The target lesion was located in the ostium of the right coronary artery.A 4.5mm x 12mm synergy megatron drug-eluting stent was implanted successfully at nominal pressures.Ostial flaring of the stent was then performed at 16atm.Upon withdrawal, the shaft was very snug/tight on the wire and not moving.The stent balloon was approximately 80% outside of the guide and could not be withdrawn any further.With gentle manipulation to get the balloon free from the wire, the shaft became free, however, it had detached/broken off of the balloon.An attempt to remove the whole system (balloon + wire) out as one unit was successful up to the brachial artery region, where the balloon came off the wire and was hanging free in the brachial artery.Removal attempts were unsuccessful and the patient required invasive surgery to remove the device fragment.The stent procedure was completed successfully.The patient is doing well with no further patient complications reported.It was further reported that resistance was met in withdrawing the stent balloon from vessel to guide, after deploying the stent.It moved very little and only came back about 20% into the guide.Before pulling back the device, the physician waited long enough for the balloon to be fully deflated with no contrast in it on fluoroscopy.It was noted that it was a large 4.5 balloon, and that the physician waited anywhere up to 10 seconds prior to removing the balloon.Absence of contrast was confirmed within the balloon under fluoroscopy.No further patient complications were reported in relation to this event.It was further reported that the initial deflation time was 15 seconds and there was no contrast visible in balloon.Then, the physician did an extra 2 deflations and overall deflation time would have been in excess of 30 seconds.It was further reported that a 16 mm x 4.50 mm synergy megatron drug-eluting stent was implanted in the proximal to mid rca, a 4.5mm x 12mm synergy megatron drug-eluting stent was then positioned and deployed in the ostial to proximal rca.The deflation of balloon was performed for a prolonged period.The exact time is not recorded, but the balloon was fully deflated with no contrast inside it on the angiogram.There was difficulty in removing the balloon, the catheter was stuck on the wire, further two deflations were performed for a prolonged period, with the 'inflation device assist' remaining on negative suction/vacuum.Overall, there were three deflations and process of monitoring the balloon angiographically, deflation time was more than 60 seconds.Despite these multiple deflations and having no contrast in the balloon, it remained stuck to the wire and would not move.

Manufacturer Narrative

Device evaluated by mfr.: the complaint device was not received for analysis however seventeen angiographic images were received and reviewed.A guide catheter was in position at the rca ostium with a guidewire through the artery.A bsc stent is noted to be positioned and deployed in prox to mid rca.A second bsc stent is then positioned and deployed in ostial to proximal rca overlapping the previous non bsc deployed stent.Postdilation of the first megatron stent and of the second bsc stent overlapped region is noted.Withdrawal of the delivery balloon form the rca is not capture on media.Markerbands corresponding to the stent delivery system balloon are noted in the brachial artery.This suggests the delivery balloon was detached from the delivery system.Unsuccessful attempts to remove the balloon with a snare are noted in the last few series.A review of the media provided could identify the alleged balloon detachment, as the images provided showed a delivery system balloon loose in the brachial artery and attempted via a snare.No withdrawal attempts of the stent delivery system from the deployed megaton stent were captured in the images available.

Event Description

It was reported that shaft break and surgical intervention occurred.The target lesion was located in the ostium of the right coronary artery.A 4.5mm x 12mm synergy megatron drug-eluting stent was implanted successfully at nominal pressures.Ostial flaring of the stent was then performed at 16atm.Upon withdrawal, the shaft was very snug/tight on the wire and not moving.The stent balloon was approximately 80% outside of the guide and could not be withdrawn any further.With gentle manipulation to get the balloon free from the wire, the shaft became free, however, it had detached/broken off of the balloon.An attempt to remove the whole system (balloon + wire) out as one unit was successful up to the brachial artery region, where the balloon came off the wire and was hanging free in the brachial artery.Removal attempts were unsuccessful and the patient required invasive surgery to remove the device fragment.The stent procedure was completed successfully.The patient is doing well with no further patient complications reported.It was further reported that resistance was met in withdrawing the stent balloon from vessel to guide, after deploying the stent.It moved very little and only came back about 20% into the guide.Before pulling back the device, the physician waited long enough for the balloon to be fully deflated with no contrast in it on fluoroscopy.It was noted that it was a large 4.5 balloon, and that the physician waited anywhere up to 10 seconds prior to removing the balloon.Absence of contrast was confirmed within the balloon under fluoroscopy.No further patient complications were reported in relation to this event.

Event Description

It was reported that shaft break and surgical intervention occurred.The target lesion was located in the ostium of the right coronary artery.A 4.5mm x 12mm synergy megatron drug-eluting stent was implanted successfully at nominal pressures.Ostial flaring of the stent was then performed at 16atm.Upon withdrawal, the shaft was very snug/tight on the wire and not moving.The stent balloon was approximately 80% outside of the guide and could not be withdrawn any further.With gentle manipulation to get the balloon free from the wire, the shaft became free, however, it had detached/broken off of the balloon.An attempt to remove the whole system (balloon + wire) out as one unit was successful up to the brachial artery region, where the balloon came off the wire and was hanging free in the brachial artery.Removal attempts were unsuccessful and the patient required invasive surgery to remove the device fragment.The stent procedure was completed successfully.The patient is doing well with no further patient complications reported.It was further reported that resistance was met in withdrawing the stent balloon from vessel to guide, after deploying the stent.It moved very little and only came back about 20% into the guide.Before pulling back the device, the physician waited long enough for the balloon to be fully deflated with no contrast in it on fluoroscopy.It was noted that it was a large 4.5 balloon, and that the physician waited anywhere up to 10 seconds prior to removing the balloon.Absence of contrast was confirmed within the balloon under fluoroscopy.No further patient complications were reported in relation to this event.It was further reported that the initial deflation time was 15 seconds and there was no contrast visible in balloon.Then, the physician did an extra 2 deflations and overall deflation time would have been in excess of 30 seconds.It was further reported that a 16 mm x 4.50 mm synergy megatron drug-eluting stent was implanted in the proximal to mid rca, a 4.5mm x 12mm synergy megatron drug-eluting stent was then positioned and deployed in the ostial to proximal rca.The deflation of balloon was performed for a prolonged period.The exact time is not recorded, but the balloon was fully deflated with no contrast inside it on the angiogram.There was difficulty in removing the balloon, the catheter was stuck on the wire, further two deflations were performed for a prolonged period, with the 'inflation device assist' remaining on negative suction/vacuum.Overall, there were three deflations and process of monitoring the balloon angiographically, deflation time was more than 60 seconds.Despite these multiple deflations and having no contrast in the balloon, it remained stuck to the wire and would not move.

Manufacturer Narrative

Device evaluated by mfr.: the complaint device was not received for analysis however seventeen angiographic images were received and reviewed.A guide catheter was in position at the rca ostium with a guidewire through the artery.A bsc stent is noted to be positioned and deployed in prox to mid rca.A second bsc stent is then positioned and deployed in ostial to proximal rca overlapping the previous non bsc deployed stent.Postdilation of the first megatron stent and of the second bsc stent overlapped region is noted.Withdrawal of the delivery balloon form the rca is not capture on media.Markerbands corresponding to the stent delivery system balloon are noted in the brachial artery.This suggests the delivery balloon was detached from the delivery system.Unsuccessful attempts to remove the balloon with a snare are noted in the last few series.A review of the media provided could identify the alleged balloon detachment, as the images provided showed a delivery system balloon loose in the brachial artery and attempted via a snare.No withdrawal attempts of the stent delivery system from the deployed megaton stent were captured in the images available.

• Brand Name: SYNERGY MEGATRON
• Type of Device: 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: 15404163
• MDR Text Key: 299718348
• Report Number: 2124215-2022-32595
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/12/2023

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
• Device Expiration Date: 12/17/2023
• Device Lot Number: 0028630801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 09/12/2022; 11/02/2022; 12/07/2022; 01/04/2023
• Supplement Dates FDA Received: 10/04/2022; 11/18/2022; 12/22/2022; 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2021
• 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