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

Model Number	10604
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery (rca).A 3.50 x 24 synergy ii drug-eluting stent was advanced for treatment.However, during the procedure, the stent was dislodged from the balloon prior to deployment and could not be retrieved.The stent traveled from the ostium of the rca to the internal iliac where it became lodged in a calcified disease.It was decided that the placement of the dislodged stent in the internal iliac did not present immediate danger to the patient and that the stent could not be retrieved with a snare.The procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that stent dislodgement occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery (rca).A 3.50 x 24 synergy ii drug-eluting stent was advanced for treatment.However, during the procedure, the stent was dislodged from the balloon prior to deployment and could not be retrieved.The stent traveled from the ostium of the rca to the internal iliac where it became lodged in a calcified disease.It was decided that the placement of the dislodged stent in the internal iliac did not present immediate danger to the patient and that the stent could not be retrieved with a snare.The procedure was completed with another of same device.No patient complications were reported.It was further reported that following rotablation, the physician experienced resistance delivering the 3.50 x 24 synergy stent to overlap the previously placed stent in the proximal rca.The physician attempted to pull the stent back into the guide.The stent delivery system (sds) was removed and it was then noticed that the undeployed stent had come off from the sds.
Additional Manufacturer Narrative
The synergy ii us mr 3.50 x 24 stent delivery system was returned for analysis without the stent.The stent was not returned with the device.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture was within max crimped stent profile measurement.The balloon cones were reviewed, and no signs of positive pressure applied to the cones were noted as the wings were tightly folded.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks along several locations of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.The review of the two images provided could identify the alleged stent dislodgement as an unexpanded stent was noted without its delivery system in a region of the patient body corresponding with the iliac artery.As per event description a possible interaction occurred between the stent and the distal end of the guide catheter as well as the previously deployed stent (resistance delivering the stent to overlap the previously deployed one) could have occurred which caused the unexpanded stent to get caught and dislodged from the delivery system.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent dislodgement occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery (rca).A 3.50 x 24 synergy ii drug-eluting stent was advanced for treatment.However, during the procedure, the stent was dislodged from the balloon prior to deployment and could not be retrieved.The stent traveled from the ostium of the rca to the internal iliac where it became lodged in a calcified disease.It was decided that the placement of the dislodged stent in the internal iliac did not present immediate danger to the patient and that the stent could not be retrieved with a snare.The procedure was completed with another of same device.No patient complications were reported.It was further reported that following rotablation, the physician experienced resistance delivering the 3.50 x 24 synergy stent to overlap the previously placed stent in the proximal rca.The physician attempted to pull the stent back into the guide.The stent delivery system (sds) was removed and it was then noticed that the undeployed stent had come off from the sds.

• 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: 12332899
• Report Number: 2134265-2021-10478
• Device Sequence Number: 4425135
• Product Code: NIQ
• UDI-Device Identifier: 08714729840244
• UDI-Public: 08714729840244
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/07/2021

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: 10/22/2022
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0026282213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 08/24/2021; 09/29/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/09/2021; 10/07/2021
• 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: Required Intervention