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

Model Number	10602
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in a calcified vessel.A 3.00 x 16 synergy drug-eluting stent was advanced for treatment.However, during the procedure, the stent was caught on the calcium and was pushed back onto the catheter.The balloon was inflated in the lesion but no stent was deployed because the stent was on the stent catheter and not on the balloon.There were no patient complications reported.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in a calcified vessel.A 3.00 x 16 synergy drug-eluting stent was advanced for treatment.However, during the procedure, the stent was caught on the calcium and was pushed back onto the catheter.The balloon was inflated in the lesion but no stent was deployed because the stent was on the stent catheter and not on the balloon.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 3.00 x 16mm stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.The stent had moved proximally on the balloon with the majority of the stent on the distal shaft.The entire length of the stent was stretched with struts lifted along the length.Due to the stent movement and damage, an undamaged stent outer diameter)measurement was not possible to obtain.The balloon cones were reviewed, and issues were noted.The balloon appeared inflated and deflated with balloon folds relaxed.A visual and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube shaft.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.

• 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: 10831627
• Report Number: 2134265-2020-15600
• Device Sequence Number: 2904647
• Product Code: NIQ
• UDI-Device Identifier: 08714729840114
• UDI-Public: 08714729840114
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/16/2020

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: 08/07/2022
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0025859300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1