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

Model Number 10622

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)

Patient Problems Renal Failure (2041); Heart Failure (2206); Injury (2348); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that deflation failure occurred resulting in complications.Vascular access was obtained via the right femoral artery.A percutaneous coronary intervention was performed on a de novo target lesion located in the stenosed, severely tortuous and moderately calcified mid right coronary artery (rca).Pre-dilation was performed.A 3.50 x 32 synergy stent was advanced with significant resistance noted.The stent was deployed at 14 bar.It was noted that the balloon inflation was slow, but it was able to be fully inflated without waist.The stent was fully deployed and well apposed.The balloon would only partially deflate after several attempts.The physician attempted to withdraw the balloon several times, without exerting force.Then the stent delivery system was withdrawn suddenly.The shaft of the delivery system was not kinked, but the balloon had torn off at the end of the shaft and remained in the stent.White threads hung from the distal end of the shaft, which was likely due to the detached balloon.A promus select was then advanced and deployed inside the synergy stent.The detached synergy stent balloon was fixed between the two stent layers and the issue was considered resolved.The procedure was completed.The event resulted in delayed vessel closure of 45 minutes and required additional contrast media (contrast ratio in the inflation device was at 50%) resulting in heart failure and the patient now requires dialysis.There were no further patient complications.

Manufacturer Narrative

Initial reporter phone: (b)(6).Correction: h6: changed from injury 2348 to renal failure 2041.

Event Description

It was reported that difficulty advancing, difficulty removing, failure to deflate a balloon, balloon damage, unretrieved device, additional intervention, prolonged procedure, heart failure, and permanent impairment of body function occurred.Vascular access was obtained via the right femoral artery.A percutaneous coronary intervention was performed on a de novo target lesion located in the severely tortuous and moderately calcified middle right coronary artery (rca).A 3.50 x 32 synergy stent was advanced and deployed, but significant resistance occurred while advancing and withdrawing the device.It was noted that the stent was fully deployed and well apposed.Following stent deployment, the balloon was inflated to 14 bar.It was noticed that there was difficulty inflating the balloon, as it was slow to inflate.It was noted that it was taking a longer time than normal.The stent balloon fully inflated without waist.Deflation of the stent balloon was attempted, but was not possible.The balloon only partially deflated and there was difficulty removing the balloon from the stent.After several attempts, it only partially emptied.Several attempts, without exerting force, were made to withdraw the balloon.Suddenly, the stent delivery system was withdrawn, but it was noted that this was not normal.The shaft of the stent balloon was not kinked, but the balloon had torn off at the end of the shaft, and remained in the stent.It was noticed that white threads hung from the distal end of the shaft, which was likely due to the detached balloon.A promus select was then advanced and deployed inside the synergy stent.The detached stent balloon was fixed between the two stent layers, and the problem was then noted to be resolved.The procedure was completed.The event resulted in a long procedure time (45 minutes closure of the vessel) and required more contrast media (contrast ratio in the inflation device was at 50%), which resulted in heart failure and permanent impairment of a body function as the patient required dialysis.No further patient complications were reported in relation to this event.It was further reported that the target lesion was a very long lesion, with the tightest portion of 80% stenosed.Inflation was noted to not be a problem, but was a gradual inflation starting from 6 atmospheres to higher.It was noted that the reason for deflation difficulties was likely due to the very torque and calcified rca.Furthermore passage of the stent was possible only with support of a guidezilla guide extension catheter in the right judkin 4, 0 7f.It was additionally noted that the reopening of the artery and over stenting the balloon was successful.The patient was hemodynamically and respiratory stable during the entire procedure.However, he experienced worsening of his chronic kidney failure, which required temporary dialysis.It was lastly noted that after a prolonged hospitalization, the patient was discharged to home in a good clinical condition.It was further reported that the balloon appeared to be empty while attempting to deflate the balloon.The shaft of this balloon had no breaks during inflation and when it was removed from the catheter.The detachment point was in the connection between the shaft and the balloon.The stent balloon was inflated as usual in nearly 6 to 8 seconds, it remained inflated for another 10 seconds.In total, the inflation time was 16 to 18 seconds.10 to12 seconds were waited for the balloon deflate before an attempt was made to withdraw the delivery balloon from the stent.It was noted that this is the usual time to wait for the stent balloons to deflate for stent balloons longer than 25mm.The entire balloon, while the metallic part of the shaft was completely outside the patient.The break was in the distal polymer shaft.It was noticed that there were 3 to 4 stripes of plastic at the end of the broken shaft.It was clarified that only two balloon stents were deployed to cover the detached balloon section.It was noted that the middle part of the remaining balloon was only post dilated since a large side branch was jeopardized.It was noted that a routinely used inflation device for other of the same procedures in the cath lab was used during this procedure.No further patient complications were reported in relation to this event.

Manufacturer Narrative

Initial reporter phone: (b)(6).

Event Description

It was reported that difficulty advancing, difficulty removing, failure to deflate a balloon, balloon damage, unretrieved device, additional intervention, prolonged procedure, heart failure, and permanent impairment of body function occurred.Vascular access was obtained via the right femoral artery.A percutaneous coronary intervention was performed on a de novo target lesion located in the severely tortuous and moderately calcified middle right coronary artery (rca).A 3.50 x 32 synergy stent was advanced and deployed, but significant resistance occurred while advancing and withdrawing the device.It was noted that the stent was fully deployed and well apposed.Following stent deployment, the balloon was inflated to 14 bar.It was noticed that there was difficulty inflating the balloon, as it was slow to inflate.It was noted that it was taking a longer time than normal.The stent balloon fully inflated without waist.Deflation of the stent balloon was attempted, but was not possible.The balloon only partially deflated and there was difficulty removing the balloon from the stent.After several attempts, it only partially emptied.Several attempts, without exerting force, were made to withdraw the balloon.Suddenly, the stent delivery system was withdrawn, but it was noted that this was not normal.The shaft of the stent balloon was not kinked, but the balloon had torn off at the end of the shaft, and remained in the stent.It was noticed that white threads hung from the distal end of the shaft, which was likely due to the detached balloon.A promus select was then advanced and deployed inside the synergy stent.The detached stent balloon was fixed between the two stent layers, and the problem was then noted to be resolved.The procedure was completed.The event resulted in a long procedure time (45 minutes closure of the vessel) and required more contrast media (contrast ratio in the inflation device was at 50%), which resulted in heart failure and permanent impairment of a body function as the patient required dialysis.No further patient complications were reported in relation to this event.It was further reported that the target lesion was a very long lesion, with the tightest portion of 80% stenosed.Inflation was noted to not be a problem, but was a gradual inflation starting from 6 atmospheres to higher.It was noted that the reason for deflation difficulties was likely due to the very torque and calcified rca.Furthermore passage of the stent was possible only with support of a guidezilla guide extension catheter in another manufactures 4, 0 7fr coronary catheter.It was additionally noted that the reopening of the artery and over stenting the balloon was successful.The patient was hemodynamically and respiratory stable during the entire procedure.However, he experienced worsening of his chronic kidney failure, which required temporary dialysis.It was lastly noted that after a prolonged hospitalization, the patient was discharged to home in a good clinical condition.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10652974
• MDR Text Key: 210578244
• Report Number: 2134265-2020-13419
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2020
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0023613735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 58 YR