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

Model Number 10619

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

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

Event Date 09/15/2021

Event Type  malfunction  

Event Description

It was reported that difficulty removing a balloon occurred.A percutaneous coronary intervention (pci) was performed on an 80% stenosed lesion located in the mildly calcified left main (lm) artery.Following predilatation, a 4.50 x 20 synergy stent was advanced.The stent delivery balloon was inflated to 16 atmospheres for 20 seconds.The 4.50 x 20 synergy stent was deployed in the lm.The stent delivery balloon was deflated and 40 seconds was waited to retrieve the balloon.There were difficulties removing the stent delivery balloon.The stent delivery balloon was stuck to 4.50 x 20 synergy stent.The stent delivery balloon was then inflated to 18 atmospheres.There was still difficulty retrieving the stent delivery balloon.Force was used to remove the stent delivery balloon.It was noted that stent delivery balloon was still partially inflated and intact at the time of removal.There was no physical damage noticed to the synergy stent delivery system.The procedure was completed.There was no patient complications reported in relation to this event.

Event Description

It was reported that difficulty removing a balloon occurred.A percutaneous coronary intervention (pci) was performed on an 80% stenosed lesion located in the mildly calcified left main (lm) artery.Following predilatation, a 4.50 x 20 synergy stent was advanced.The stent delivery balloon was inflated to 16 atmospheres for 20 seconds.The 4.50 x 20 synergy stent was deployed in the lm.The stent delivery balloon was deflated and 40 seconds was waited to retrieve the balloon.There were difficulties removing the stent delivery balloon.The stent delivery balloon was stuck to 4.50 x 20 synergy stent.The stent delivery balloon was then inflated to 18 atmospheres.There was still difficulty retrieving the stent delivery balloon.Force was used to remove the stent delivery balloon.It was noted that stent delivery balloon was still partially inflated and intact at the time of removal.There was no physical damage noticed to the synergy stent delivery system.The procedure was completed.There was no patient complications reported in relation to this event.It was further reported that resistance first occurred while trying to withdraw the balloon from the stent.Issues occurred when attempting to remove the balloon from the drug eluting stent, and while withdrawing the balloon from the guide catheter.It was further reported that the stent was not positioned at an angulated or constricted region.The stent was deployed and apposed to the vessel walls without issues.Post dilation of the balloon to further post dilate the deployed stent was not performed.It was noted that the issue was not with dilatation of the deployed stent, but was initially a struggle with the stent balloon.It was noted that there was not really any significant constriction noted on the deployed stent, fibrotic, or calcific nodules present.

Event Description

It was reported that difficulty removing a balloon occurred.A percutaneous coronary intervention (pci) was performed on an 80% stenosed lesion located in the mildly calcified left main (lm) artery.Following predilatation, a 4.50 x 20 synergy stent was advanced.The stent delivery balloon was inflated to 16 atmospheres for 20 seconds.The 4.50 x 20 synergy stent was deployed in the lm.The stent delivery balloon was deflated and 40 seconds was waited to retrieve the balloon.There were difficulties removing the stent delivery balloon.The stent delivery balloon was stuck to 4.50 x 20 synergy stent.The stent delivery balloon was then inflated to 18 atmospheres.There was still difficulty retrieving the stent delivery balloon.Force was used to remove the stent delivery balloon.It was noted that stent delivery balloon was still partially inflated and intact at the time of removal.There was no physical damage noticed to the synergy stent delivery system.The procedure was completed.There was no patient complications reported in relation to this event.It was further reported that resistance occurred while trying to withdraw the balloon from the guide catheter.

Manufacturer Narrative

Device evaluated by mfr: a 4.50 x 20 mm synergy stent delivery system (sds) was returned for analysis without the stent.The device was returned without the stent as it was deployed successfully at the lesion site.The balloon cones were reviewed, and signs of positive pressure were noted as its wings were relaxed.A visual and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the outer and mid shaft section and a visual examination of the inner lumen found no issues.The device was loaded successfully onto 0.0140 inch test guidewire.An inflation attempt was made using an encore device and the balloon inflated with no issues.No damage to the balloon.Encore inflation device was verified before and after usage.No issues were identified during the product analysis.

Event Description

It was reported that difficulty removing a balloon occurred.A percutaneous coronary intervention (pci) was performed on an 80% stenosed lesion located in the mildly calcified left main (lm) artery.Following predilatation, a 4.50 x 20 synergy stent was advanced.The stent delivery balloon was inflated to 16 atmospheres for 20 seconds.The 4.50 x 20 synergy stent was deployed in the lm.The stent delivery balloon was deflated and 40 seconds was waited to retrieve the balloon.There were difficulties removing the stent delivery balloon.The stent delivery balloon was stuck to 4.50 x 20 synergy stent.The stent delivery balloon was then inflated to 18 atmospheres.There was still difficulty retrieving the stent delivery balloon.Force was used to remove the stent delivery balloon.It was noted that stent delivery balloon was still partially inflated and intact at the time of removal.There was no physical damage noticed to the synergy stent delivery system.The procedure was completed.There was no patient complications reported in relation to this event.It was further reported that resistance first occurred while trying to withdraw the balloon from the stent.Issues occurred when attempting to remove the balloon from the drug eluting stent, and while withdrawing the balloon from the guide catheter.It was further reported that the stent was not positioned at an angulated or constricted region.The stent was deployed and apposed to the vessel walls without issues.Post dilation of the balloon to further post dilate the deployed stent was not performed.It was noted that the issue was not with dilatation of the deployed stent, but was initially a struggle with the stent balloon.It was noted that there was not really any significant constriction noted on the deployed stent, fibrotic, or calcific nodules present.

• Brand Name: SYNERGY
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12513552
• MDR Text Key: 272724049
• Report Number: 2134265-2021-11948
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2022
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0025281122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1