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

Model Number	10607
Medical Device Problem Codes	Break (1069); Activation Failure (3270); Migration (4003)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent insufficient apposition and shaft break occurred, and that the patient had a stroke.The target lesion was located in the calcified left circumflex artery.After a wire crossed the lesion, a 2.50x38mm synergy drug-eluting stent was advanced to treat the lesion.When the stent was being inflated up to 8 atmospheres, the pressure was lost which left the stent partially inflated.As the stent delivery system (sds) was being removed the shaft broke proximal to the wire exit port.The physician was able to remove the distal shaft and delivery balloon by trapping the sds with a balloon inside the guide.It was visualized that part of the stent had migrated to the aorta.After repeated attempts to rewire through the stent, the decision was made to stop the case and consult other physicians for options.The patient was brought back to the lab where the interventional radiologist was able to successfully snare the stent and remove it from the body.Post-procedure, the patient had a stroke.Two days later, the patient was still in the hospital.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.50 x 38 mm stent delivery system (sds).A visual examination of the crimped stent found that the stent had detached from the sds and was severely damaged the whole length with stent struts stretched.As part of the analysis, a review of the manufacturing data for the stent profile was performed.The maximum crimped stent profile measurement at the time of manufacture was within specification.A visual examination of the bumper tip showed signs of damage.Tip damage most likely occurred during withdrawal attempts.The balloon body was reviewed, and red/brown like substance resembling blood was observed inside the balloon body which is an indication of a leak.The balloon had wings were relaxed indicating that positive pressure was applied.A visual and tactile examination found multiple kinks along the hypotube shaft.The laser-cut region was also observed to be fractured at 110.5 cm distal to the distal end of the strain relief.This type of damage is consistent with excessive force that could have been applied to the delivery system.A visual and tactile examination of the outer extrusion and mid-shaft section and visual examination of the inner extrusion showed multiple kinks along the extrusion shaft.The shaft polymer extrusion was noted to be broken at approximately 119 cm distal to the distal end of the strain relief.This type of damage is consistent with excessive force that could have been applied to the delivery system.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent insufficient apposition and shaft break occurred, and that the patient had a stroke.The target lesion was located in the calcified left circumflex artery.After a wire crossed the lesion, a 2.50x38mm synergy drug-eluting stent was advanced to treat the lesion.When the stent was being inflated up to 8 atmospheres, the pressure was lost which left the stent partially inflated.As the stent delivery system (sds) was being removed the shaft broke proximal to the wire exit port.The physician was able to remove the distal shaft and delivery balloon by trapping the sds with a balloon inside the guide.It was visualized that part of the stent had migrated to the aorta.After repeated attempts to rewire through the stent, the decision was made to stop the case and consult other physicians for options.The patient was brought back to the lab where the interventional radiologist was able to successfully snare the stent and remove it from the body.Post-procedure, the patient had a stroke.Two days later, the patient was still in the hospital.

• 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: 9405519
• Report Number: 2134265-2019-14577
• Device Sequence Number: 2626371
• Product Code: NIQ
• UDI-Device Identifier: 08714729840398
• UDI-Public: 08714729840398
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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 Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0023241457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/28/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 55 YR