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

Model Number 10632

Device Problems Break (1069); Material Separation (1562)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/18/2021

Event Type  Injury  

Event Description

Event summary: it was reported that as shaft break occurred.The 3.00 x 48mm synergy drug eluted stent was selected for a percutaneous coronary intervention (pci).During procedure, the stent was under deployed and the shaft of the delivery system broken when the physician trying to extract balloon.The radiopaque markers stuck in the left anterior descending artery.They attempted to snared out the device unsuccessfully.There were no patient complications reported.Patient status: there were no patient complications reported.

Event Description

It was reported that as shaft break occurred.The 3.00 x 48mm synergy drug eluted stent was selected for a percutaneous coronary intervention (pci).During procedure, the stent deployed and the shaft of the delivery system broken when the physician trying to extract balloon.The device was snared out and it was completely removed from the patient.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr: a synergy ous mr 3.00 x 48mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent identified that the device was returned with no stent attached due to the stent being successfully implanted in the patient.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacturing was within max crimped stent profile measurement.A visual and tactile examination of the hypotube found a partial hypotube break in laser-cut region at 3 cm distal of the midshaft-hypotube bond and a midshaft break at 12.5 cm distal of the midshaft-hypotube bond.The balloon, shaft polymer extrusion and tip were not returned with the device.

• 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: 12138984
• MDR Text Key: 260688683
• Report Number: 2134265-2021-08718
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2022
• Device Model Number: 10632
• Device Catalogue Number: 10632
• Device Lot Number: 0025901092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention