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

Lot Number	0030582928
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3.Date of event- used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that shaft break, removal difficulties, and additional surgery occurred.The patient was presented with renal disease and underwent renal angioplasty.Following placement of a 6fr sheath.A 5.00 x 16mm synergy megatron stent was advanced for treatment.However, there was difficulty pulling the balloon into the guide and the stent balloon broke off in the patient's brachial artery.The physician attempted to snare the device but could not capture it.Vascular surgery cutdown was done to remove the megatron stent.The procedure was aborted.There were no further patient complications nor injuries reported and the patient had fully recovered.
Additional Manufacturer Narrative
B3.Date of event- used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.Product analysis: a synergy megatron mr us 5.00 x 16mm, manifold was returned for analysis.A visual, tactile and microscopic examination was performed in the device.The device was received in two sections as a result of a break which had occurred in the hypotube.A visual and tactile examination identified multiple kinks along the distal section of the break.The entire distal extrusion was severely stretched and flattened.A break occurred in the shaft at the location of the proximal balloon sleeve.As a result of the break, the balloon detached from the main catheter.A visual examination of the balloon confirmed that the stent was deployed from the balloon.No tears were visible in the balloon material.A microscopic examination of the distal extrusion identified that the lesion was stretched and bunched at various locations along its length.A break was present in the shaft at the location of the proximal balloon sleeve.The break is consistent excessive tensile forces having been applied to the device.A microscopic examination of the balloon material identified no tears or holes in the balloon material.The balloon was detached from the main delivery catheter due to a break in the distal extrusion.A microscopic examination of the break site in the distal extrusion, at the proximal balloon sleeve, noted that due to the severe stretch down on the inner shaft the proximal markerband was pulled into the proximal sleeve of the balloon.The distal tip edge of the device was pinched closed.These examinations confirmed that excessive tensile forces had been applied to the device which resulted in the severe stretching and bunching along the distal extrusion.A break had also occurred in the distal extrusion shaft in the location of the proximal balloon sleeve.As a rest, the balloon was detached from the main catheter.Further examinations of the device noted that due to the severe stretching in the distal extrusion the proximal markerband had been pulled into the proximal sleeve in the balloon.A detailed microscopic examination of the balloon material identified no tears or holes in the balloon material.
Event or Problem Description
It was reported that shaft break, removal difficulties, and additional surgery occurred.The patient was presented with renal disease and underwent renal angioplasty.Following placement of a 6fr sheath.A 5.00 x 16mm synergy megatron stent was advanced for treatment.However, there was difficulty pulling the balloon into the guide and the stent balloon broke off in the patient's brachial artery.The physician attempted to snare the device but could not capture it.Vascular surgery cutdown was done to remove the megatron stent.The procedure was aborted.There were no further patient complications nor injuries reported and the patient had fully recovered.

• Brand Name: SYNERGY MEGATRON
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17233253
• Report Number: 2124215-2023-32594
• Device Sequence Number: 17995487
• Product Code: NIQ
• UDI-Device Identifier: 08714729985648
• UDI-Public: 08714729985648
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2023
• Device Lot Number: 0030582928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown