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

Lot Number 0029516430

Device Problem Failure to Deflate (4060)

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

Event Date 05/09/2023

Event Type  malfunction  

Event Description

It was reported that deflation issue occurred.During procedure, a 2.50 x 24mm synergy xd drug-eluting stent was advanced to treat the lesion.However, it was noticed that the balloon would not deflate with the guidewire.The procedure was completed with a different device.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

Device evaluated by mfr.: synergy xd mr ous 2.50 x 24mm stent delivery system, catheter was returned for analysis.Visual, tactile, microscopic, dimensional, and functional analysis was performed on the device.Stent damaged was noted at the mid-section of the stent where stent struts were lifted and pulled off balloon.No signs of movement, stent was set between the proximal and distal markerbands.The crimped stent outer diameter was measured, and the result is within max crimped stent profile measurement.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 issues identified with the hypotube shaft.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.Bumper tip showed no signs of distal tip damage.The device could also be inflated to rbp and deflated with no issues.

Event Description

It was reported that deflation issue occurred.During procedure, a 2.50 x 24mm synergy xd drug-eluting stent was advanced to treat the lesion.However, it was noticed that the balloon would not deflate with the guidewire.The procedure was completed with a different device.There were no patient complications reported and the patient status was stable.

• Brand Name: SYNERGY XD
• 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: 17035016
• MDR Text Key: 316293501
• Report Number: 2124215-2023-26386
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2024
• Device Lot Number: 0029516430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 05/31/2023
• Supplement Dates Manufacturer Received: 07/05/2023
• Supplement Dates FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• 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 Sex: Male