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

Model Number 10621

Device Problems Material Rupture (1546); Material Deformation (2976)

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

Event Date 12/25/2023

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.50 x 28 synergy drug-eluting stent was advanced for treatment.However, it was noted that the stent balloon burst.The procedure was completed successfully with another of the same device.There were no patient complications or injuries reported and patient condition is stable.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter phone number: (b)(6).

Manufacturer Narrative

Updated: e6: device code from material rupture to material deformation.E1: initial reporter facility name: (b)(6).E1: initial reporter phone number: (b)(6).

Event Description

It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.50 x 28 synergy drug-eluting stent was advanced for treatment.However, it was noted that the stent balloon burst.The procedure was completed successfully with another of the same device.There were no patient complications or injuries reported and patient condition is stable.It was further reported that the stent was lifted up, not a balloon ruptured as what previously reported and the device was removed intact.

Event Description

It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.50 x 28 synergy drug-eluting stent was advanced for treatment.However, it was noted that the stent balloon burst.The procedure was completed successfully with another of the same device.There were no patient complications or injuries reported and patient condition is stable.It was further reported that the stent was lifted up, not a balloon ruptured as what previously reported and the device was removed intact.

Manufacturer Narrative

Device evaluated by mfr.: synergy ous mr 2.50 x 28mm stent delivery system was returned for analysis.Visual and tactile inspection identified no issues with the hypotube shaft.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.Microscopic examination identified no sign of damage, stretching or lifting of the stent struts.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.No signs of movement, stent was set between the proximal and distal markerbands.Bumper tip showed no signs of distal tip damage.The crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.No device issues were identified during returned product analysis.(b)(6).

• Brand Name: SYNERGY
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18580309
• MDR Text Key: 334663641
• Report Number: 2124215-2024-02647
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0030537863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• 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