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

Model Number	10607
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent premature deployment occurred.The target lesion was located in the non-tortuous and non-calcified left anterior descending artery.A 2.50x38mm synergy drug-eluting stent was advanced for treatment.However, during procedure, the stent partially deployed from the balloon catheter before it was placed in the correct spot in the patient.The stent was able to be pulled back to the distal end of the catheter and was removed from the patient's body with the wire before it was fully deployed.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 2.50 x 38 stent delivery system was returned for analysis.Device was returned inside a eb 375.071 guidecatheter with a 0.0140" guidewire inserted through and a haemostatic valve.It was noted that the stent was bunched at the distal end of the guidecatheter and the device could not be removed.The device was soaked to allow for sds removal from guidecatheter.The device was removed from the bath and could still not be removed.The device was cut by analyst 27 cm distal to the distal end of the strain relief to allow for the distally removal of the device from within the guidecatheter.A visual examination of the stent found stent damage.Struts from the proximal to mid stent region lifted, pulled and bunched distally, struts in distal region lifted and pulled distally.The undamaged stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent premature deployment occurred.The target lesion was located in the non-tortuous and non-calcified left anterior dscending artery.A 2.50x38mm synergy drug-eluting stent was advanced for treatment.However, during procedure, the stent partially deployed from the balloon catheter before it was placed in the correct spot in the patient.The stent was able to be pulled back to the distal end of the catheter and was removed from the patient's body with the wire before it was fully deployed.The procedure was completed with another of same device.No patient complications were reported.

• 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: 10968766
• Report Number: 2134265-2020-17085
• Device Sequence Number: 11804380
• Product Code: NIQ
• UDI-Device Identifier: 08714729840398
• UDI-Public: 08714729840398
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0024606706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1