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

Lot Number 0029435574

Device Problems Break (1069); Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city - (b)(6).

Event Description

It was reported that a shaft break occurred.A 4.00 x 24mm synergy megatron stent balloon expandable stent was successfully placed during a percutaneous coronary intervention procedure.During inflation of the balloon, part of the balloon broke off.The physician was able to retrieve everything from the patient.No patient harm resulted in relation to this event.

Manufacturer Narrative

E1: initial reporter city (b)(6) e1: initial reporter phone number - (b)(6).Correction to h6 device code.A0412 material rupture from break a0401.

Event Description

It was reported that a shaft break occurred.A 4.00 x 24mm synergy megatron stent balloon expandable stent was successfully placed during a percutaneous coronary intervention procedure.During inflation of the balloon, part of the balloon broke off.The physician was able to retrieve everything from the patient.No patient harm resulted in relation to this event.It was further reported that synergy megatron balloon ruptured at 15 atm for 25 seconds in the right coronary artery and did not break as originally reported.The synergy megatron was fully removed.

Manufacturer Narrative

(b)(6).Device analysis by mfr: synergy megatron mr ous 4.00 x 24mm stent delivery system (sds), was returned for analysis.Based on the potential root causes identified in the fmea and the complaint report, the following attributes were examined: stent profile: the stent was not returned as balloon was inflated and stent was implanted in patient.Balloon: the balloon cones were reviewed via scope, and the balloon was in a deflated state with traces of blood inside.The distal end of the balloon was also bunched.Tip profile: a visual and microscopic examination of the bumper tip showed no issues.Hypotube profile: a visual and tactile examination of the hypotube shaft found multiple kinks along several locations of the hypotube shaft.Shaft polymer extrusion profile: a visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found that the midshaft (extrusion on proximal side of the port bond) is severely stretched with the break in the stretched part.Functional testing: could not complete functional testing due to break.No other issues were identified during the product analysis.

Event Description

It was reported that a shaft break occurred.A 4.00 x 24mm synergy megatron stent balloon expandable stent was successfully placed during a percutaneous coronary intervention procedure.During inflation of the balloon, part of the balloon broke off.The physician was able to retrieve everything from the patient.No patient harm resulted in relation to this event.It was further reported that synergy megatron balloon ruptured at 15 atm for 25 seconds in the right coronary artery and did not break as originally reported.The synergy megatron was fully removed.

• Brand Name: SYNERGY MEGATRON
• Type of Device: 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 15916047
• MDR Text Key: 307794092
• Report Number: 2124215-2022-50706
• 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
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0029435574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2022
• 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