MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC; SYNERGY XD 3.00MM X 16.0

Model Number H7493941816300

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Failure to Advance (2524); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 06/02/2022

Event Type  Injury  

Event Description

Per physician note: patient arrived to cardiac cath lab for cardiac catheterization with possible intervention.Following a run-through, wire was placed in the lad and attempts to advance a 3 x 16 mm synergy.Drug eluting stent were not successful due to calcification the proximal vessel so the stent was pulled back and a guide liner was then advanced for further support.Then a 2.5 x 15 mm noncompliant balloon was advanced and balloon dilation of the calcific lesion was performed.Following with a 3 x 16 mm drug-eluting stent was readvanced and inflated.Upon inflation of the balloon, it was noted that the balloon did not expand within the stent and there was contrast leakage around the delivery device and into the distal lad.Upon pulling back the delivery mechanism of the stent, there was some resistance and the delivery mechanism came out detached from the balloon and the stent.At this point attempts to rewire the lad and push the stent down using a 1.5 mm balloon was made to reestablish flow and this was successful.Subsequently an emergent impella device was then placed.The right common femoral artery was accessed via modified salinger technique using micropuncture.Initially 6 french sheath was placed in the right common femoral artery.Serial dilation was performed and 14 french impella sheath was placed in the right common femoral artery.Heparin was administered a pigtail was advanced across the aortic valve and over the wire and under fluoroscopy a percutaneous lvad impella device was advanced and placed across the aortic valve with a cardiac output of 3.5 l/min.There was no good options to the detached stent and balloon in the lad.Therefore all equipment were then pulled out a tr band was applied to the right radial artery.At the end of the procedure, the pt was hemodynamically stable chest pain-free with no ekg changes.Plans for emergent transfer to another facility for emergency cabg were made.

• Brand Name: BOSTON SCIENTIFIC
• Type of Device: SYNERGY XD 3.00MM X 16.0
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA 01752
• MDR Report Key: 14753356
• MDR Text Key: 294925207
• Report Number: 14753356
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2024
• Device Model Number: H7493941816300
• Device Lot Number: 28804354
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2022
• Distributor Facility Aware Date: 06/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White