MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10603
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	01/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the mildly tortuous left anterior descending (lad) artery.There were two layers of stents in the proximal lad.A 2.25 x 20 synergy drug-eluting stent was advanced for treatment.However, upon removal of the delivery system, the stent could no longer be visualized.At this point in time, it is believed that the stent came off of the delivery system and was lost in the patient.The patient was then sent for a computed tomography (ct) scan, and upon inspection of the patient arteries, no stent was found.In an attempt to locate the stent, the guide catheter and hemostasis valve were opened but the stent could not be found.The lesion did not get revascularized.There was no harm to the patient.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the mildly tortuous left anterior descending (lad) artery.There were two layers of stents in the proximal lad.A 2.25 x 20 synergy drug-eluting stent was advanced for treatment.However, upon removal of the delivery system, the stent could no longer be visualized.At this point in time, it is believed that the stent came off of the delivery system and was lost in the patient.The patient was then sent for a computed tomography (ct) scan, and upon inspection of the patient arteries, no stent was found.In an attempt to locate the stent, the guide catheter and hemostasis valve were opened but the stent could not be found.The lesion did not get revascularized.There was no harm to the patient.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 2.25 x 20mm stent delivery system was returned for analysis without the stent.An examination of the balloon confirmed that the crimped stent was detached from the balloon and was not returned for analysis.A review of the manufacturing stent profile data was performed and the maximum stent outer diameter was within the max crimped stent profile measurement.The balloon was reviewed, and traces of solidified contrast media was present inside the balloon, at the distal end of the balloon.This would suggest that the balloon was subjected to positive pressure.If positive pressure had been applied to the balloon, then the crimped stent securement would have been compromised.A clear impression from the initial stent crimp was evident along the balloon.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube found a break in the hypotube.The break was located at the distal end of the hub, inside the strain relief.The distal section of the hypotube break exhibited multiple kinks.The damage to the hypotube is consistent with excessive force having been applied to the shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11306856
• Report Number: 2134265-2021-00957
• Device Sequence Number: 11584958
• Product Code: NIQ
• UDI-Device Identifier: 08714729840145
• UDI-Public: 08714729840145
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/17/2021
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0024973889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other