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

Model Number 10617

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent deployment failure occurred and the procedure was not completed.The 80% stenosed target lesion was located in the ostial left main artery.A 4.00 x 12 synergy drug-eluting stent was advanced for treatment.However, during the procedure, the stent failed to expand.The device was removed and the procedure was not completed.There were no patient complications reported and the patient was stable.

Event Description

It was reported that stent deployment failure occurred and the procedure was not completed.The 80% stenosed target lesion was located in the ostial left main artery.A 4.00 x 12 synergy drug-eluting stent was advanced for treatment.However, during the procedure, the stent failed to expand.The device was removed and the procedure was not completed.There were no patient complications reported and the patient was stable.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: synergy ous mr 4.00 x 12mm stent delivery system was returned for analysis.A visual examination of the stent found the stent damaged - stent struts in the distal region were lifted from the crimped position.The undamaged stent outer diameter was within maximum crimped stent profile measurement.The balloon was reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.Initial device inflation was attempted but failed due to residue in the inflation lumen.The device was then placed in a water bath for soaking.Following soaking, the device was loaded onto a 0.014" guide wire.The balloon was inflated with no issues.Vacuum was pulled and the balloon deflated with no issues.The encore inflation device was verified before and after use.No other 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
• MDR Report Key: 10356814
• MDR Text Key: 201582299
• Report Number: 2134265-2020-09542
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2020
• Device Model Number: 10617
• Device Catalogue Number: 10617
• Device Lot Number: 0023217095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 60