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

Model Number 10623

Device Problems Break (1069); Deflation Problem (1149); Material Integrity Problem (2978)

Patient Problem Ventricular Fibrillation (2130)

Event Date 01/12/2022

Event Type  Injury  

Event Description

It was reported that ventricular fibrillation occurred.A 3.50 x 38 synergy drug-eluting stent was selected for coronary angioplasty procedure in a none calcified artery.The lesion was not predilated.During procedure, the stent was implanted, but the balloon failed to deflate in the middle third of the right coronary artery.The balloon was filled with a low density of the contrast solution.Due to the balloon failure to deflate, the patient presented ventricular fibrillation, which was controlled without any problem.Then, the balloon was pulled very carefully, the balloon and guide catheter were successfully removed together from the coronary artery without causing damage to the patient's coronary artery.The balloon was removed in fully inflated.It was noticed that the balloon hypotube marked elongation.The patient was treated with medication and had to be defibrillated due to ventricular fibrillation.The patient was doing well, expected to fully recover and discharged the day after the procedure.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of a 3.50 x 38 synergy stent delivery system.The device was returned for analysis in 2 sections.A stent was not returned with the device, consistent with the complaint event details.The balloon was returned in a deflated state, with traces of what appeared to be inflation media visible inside the balloon.The proximal and distal balloon cones appeared bunched.The proximal markerband was located proximal to the proximal balloon cone, indicating stretching of the inner shaft polymer extrusion.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple hypotube kinks at several locations along the hypotube shaft.The proximal hypotube was positioned between the b and s of the boston scientific logo.There we no visible blockages in the proximal hypotube.During analysis when manipulating the device, the hypotube was broken at one of the hypotube kink sites.A 0.0140" test guide wire tracked without issues through the hypotube shaft of device confirming no blockages.A visual examination of the outer and inner lumen and mid-shaft section identified a shaft break at approximately 46.5cm proximal to the distal tip, at the port bond site.Multiple shaft polymer extrusion kinks, severe stretching and flattened regions were also identified.Both the mid and distal shaft extrusions were stretched.Stretching of the inner shaft polymer extrusion was identified in the proximal markerband region, with the distance between the markerbands measuring approximately 46mm.No visible issues noted with the mid-shaft.A red blood-like substance was visible in the inflation lumen and hub.The distal shaft was cut distally to the bicomponent bond and an inflation aid was connected to the stretched and narrowed inflation lumen.The device was connected to an encore inflation device and an inflation attempt was made.The balloon inflated confirming no balloon leaks, but the deflation time could not be tested as a completed vacuum could not be pulled via needle in the distal shaft.Encore inflation device was tested before and post inflation to rbp 16 atm.Inspection of the remainder of the device revealed no damage or irregularities.

Event Description

It was reported that ventricular fibrillation occurred.A 3.50 x 38 synergy drug-eluting stent was selected for coronary angioplasty procedure in a none calcified artery.The lesion was not predilated.During procedure, the stent was implanted, but the balloon failed to deflate in the middle third of the right coronary artery.The balloon was filled with a low density of the contrast solution.Due to the balloon failure to deflate, the patient presented ventricular fibrillation, which was controlled without any problem.Then, the balloon was pulled very carefully, the balloon and guide catheter were successfully removed together from the coronary artery without causing damage to the patient's coronary artery.The balloon was removed in fully inflated.It was noticed that the balloon hypotube marked elongation.The patient was treated with medication and had to be defibrillated due to ventricular fibrillation.The patient was doing well, expected to fully recover and discharged the day after the procedure.It was further reported that a severely stenosed target lesion was located in mildly tortuous and none calcified right coronary artery.The guide catheter was used a non-boston scientific.There was no resistance noted when advancing the device in the guide catheter and over the wire prior to stent deployment.Also, there was no issues observed with balloon inflation and stent deployment.The balloon was inflated one time and inflated at 11 atmospheres between 10 to 15 seconds.The physician attempted to deflate the balloon several times by standard procedure and when the physician saw that the patient was going into ventricular fibrillation they had to remove the device urgently.The balloon was removed fully inflated, it did not deflate at all after several attempts.The patient was fine, kept under observation for 24 hours and discharged the day after the procedure.It was further reported that there was no breakage, deformation, or fragmentation of the stent delivery system during the stent implantation process.Both the elongation of the delivery system and the distal rupture occurred after complete extraction of the system, which was done by traction.Removal difficulty was encountered because the balloon was inflated, so the entire balloon delivery system, catheter and guidewire were removed during this process.There was no leakage detected in the stent delivery system during the procedure.A single balloon inflation at 12 atmospheres was performed; after eight seconds of balloon inflation, an unsuccessful attempt was made to deflate the balloon.

Event Description

It was reported that ventricular fibrillation occurred.A 3.50 x 38 synergy drug-eluting stent was selected for coronary angioplasty procedure in a none calcified artery.The lesion was not predilated.During procedure, the stent was implanted, but the balloon failed to deflate in the middle third of the right coronary artery.The balloon was filled with a low density of the contrast solution.Due to the balloon failure to deflate, the patient presented ventricular fibrillation, which was controlled without any problem.Then, the balloon was pulled very carefully, the balloon and guide catheter were successfully removed together from the coronary artery without causing damage to the patient's coronary artery.The balloon was removed in fully inflated.It was noticed that the balloon hypotube marked elongation.The patient was treated with medication and had to be defibrillated due to ventricular fibrillation.The patient was doing well, expected to fully recover and discharged the day after the procedure.It was further reported that a severely stenosed target lesion was located in mildly tortuous and none calcified right coronary artery.The guide catheter was used a non-boston scientific.There was no resistance noted when advancing the device in the guide catheter and over the wire prior to stent deployment.Also, there was no issues observed with balloon inflation and stent deployment.The balloon was inflated one time and inflated at 11 atmospheres between 10 to 15 seconds.The physician attempted to deflate the balloon several times by standard procedure and when the physician saw that the patient was going into ventricular fibrillation they had to remove the device urgently.The balloon was removed fully inflated, it did not deflate at all after several attempts.The patient was fine, kept under observation for 24 hours and discharged the day after the procedure.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13285436
• MDR Text Key: 284003564
• Report Number: 2134265-2022-00374
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2022
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0026123071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2020
• 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
• Treatment: FR4 SHERPA GUIDING CATHETER - MEDTRONIC; FR4 SHERPA GUIDING CATHETER - MEDTRONIC
• Patient Outcome(s): Other
• Patient Sex: Male