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

Lot Number 0028825190

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/25/2022

Event Type  Injury  

Event Description

It was reported that removal difficulties were encountered and an allergic reaction occurred.Procedure summary: the 70% stenosed target lesion was located in the mildly tortuous and moderately calcified proximal right coronary artery (rca).A 5.00 x 24mm synergy megatron drug-eluting stent was selected for use in the percutaneous coronary intervention (pci) procedure.The lesion pre dilated with nc balloons.During procedure, the stent was fully deployed at 18 atmospheres without any issues.During removal, the balloon of the stent was entrapped on the struts of the stent and an allergic reaction occurred with the patient.The physician tried to inflate and deflate the balloon a couple of times to remove the balloon but it was unsuccessful.The patient was sent to another hospital.A snare was used to pull the balloon out along with the stent.There were no further patient complications, the patient was stable and fully recovered.

Event Description

It was reported that removal difficulties were encountered and an allergic reaction occurred.Procedure summary: the 70% stenosed target lesion was located in the mildly tortuous and moderately calcified proximal right coronary artery (rca).A 5.00 x 24mm synergy megatron drug-eluting stent was selected for use in the percutaneous coronary intervention (pci) procedure.The lesion pre dilated with nc balloons.During procedure, the stent was fully deployed at 18 atmospheres without any issues.During removal, the balloon of the stent was entrapped on the struts of the stent and an allergic reaction occurred with the patient.The physician tried to inflate and deflate the balloon a couple of times to remove the balloon but it was unsuccessful.The patient was sent to another hospital.A snare was used to pull the balloon out along with the stent.There were no further patient complications, the patient was stable and fully recovered.It was further reported that during inflation/deflation the physician waited a couple seconds between inflation/deflation.Synergy megatron delivery system broke while inside the patient during attempts to remove it.The stent was left expanded in the artery and the delivery system was fully recaptured via a snare.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14360729
• MDR Text Key: 291415381
• Report Number: 2134265-2022-05434
• 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
• Report Date: 06/07/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2024
• Device Lot Number: 0028825190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2022
• Initial Date FDA Received: 05/11/2022
• Supplement Dates Manufacturer Received: 05/20/2022
• Supplement Dates FDA Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• 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