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

Lot Number 0029491156

Device Problems Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event- used the first date of the month of the aware date as no event date was provided.

Event Description

It was reported that balloon rupture and deflation issue occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 4.00 x 20mm synergy xd drug-eluting stent was advanced to treat the lesion.However, during the procedure, the balloon ruptured with stent deployment and would not deflate properly.The balloon was removed successfully from the patient and the procedure was completed.No patient complications were reported.

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: synergy xd mr ous 4.00 x 20mm stent delivery system was returned for analysis.The device was returned without the stent attached.A review of the manufacturing stent profile data was performed.The balloon was reviewed, and it was found to be in a partially deflated state with blood like substance visible.When inflated the balloon did not hold pressure.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found a leak at the exchange port.Encore device verified before and after use using the druck gauge to 16 atm as per indications for use.Device attempted to be inflated to rated burst pressure at 16 atm however pressure could not be maintained in the inflation device due to leak at the distal balloon cone.No other issues were identified during the product analysis.

Event Description

It was reported that balloon rupture and deflation issue occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 4.00 x 20mm synergy xd drug-eluting stent was advanced to treat the lesion.However, during the procedure, the balloon ruptured with stent deployment and would not deflate properly.The balloon was removed successfully from the patient and the procedure was completed.No patient complications were reported.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16567924
• MDR Text Key: 311560914
• Report Number: 2124215-2023-09623
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0029491156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• 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