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

Model Number 10619

Device Problem Deflation Problem (1149)

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

Event Date 05/01/2022

Event Type  malfunction  

Manufacturer Narrative

Event date unknown.

Event Description

It was reported that failure to deflate a balloon occurred.During a percutaneous coronary intervention (pci), a 4.00 x 20 synergy stent was advanced to the target lesion and deployed, but following deployment, the balloon would not deflate.Multiple attempts to deflate the balloon were performed by using an indeflator.It was confirmed that a vacuum was held during withdrawal.The balloon was finally deflated, but a residual pocket at the end of the balloon was noticed.It was noted that the balloon was mostly deflated prior to the removal attempt.The procedure was completed and no patient complications were reported in relation to this event.

Event Description

It was reported that failure to deflate a balloon occurred.During a percutaneous coronary intervention (pci), a 4.00 x 20 synergy stent was advanced to the target lesion and deployed, but following deployment, the balloon would not deflate.Multiple attempts to deflate the balloon were performed by using an inflator.It was confirmed that a vacuum was held during withdrawal.The balloon was finally deflated, but a residual pocket at the end of the balloon was noticed.It was noted that the balloon was mostly deflated prior to the removal attempt.The procedure was completed and no patient complications were reported in relation to this event.

Manufacturer Narrative

Device evaluated by manufacturer: the synergy ous mr 4.00 x 20 mm stent delivery system (sds) was returned for analysis without the stent as it was deployed successfully at the lesion site.Signs of positive pressure were noted on the balloon cones as the balloon was in a partially deflated state.No bunching of the balloon cones was noted.A functional test was performed, and the device was inflated and deflated within 15 seconds without issues.No issues were identified during the product analysis.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14547596
• MDR Text Key: 293065687
• Report Number: 2134265-2022-06122
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2022
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0026425860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2020
• 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