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

Model Number	10605
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered.The 85-90% stenosed target lesion was located in the non-tortuous and mildly calcified mid left anterior descending artery.A 3.50 x 28 synergy ii drug-eluting stent was deployed for treatment.However, when pulling the stent delivery system (sds) back into the guide catheter, the distal end of the sds would not go into the guide.The physician had to pull everything out and it was noticed that the balloon did not completely re-wrap at the distal tip of the stent delivery system.The procedure was completed and there were no patient complications nor injuries reported.
Event or Problem Description
It was reported that removal difficulties were encountered.The 85-90% stenosed target lesion was located in the non-tortuous and mildly calcified mid left anterior descending artery.A 3.50 x 28 synergy ii drug-eluting stent was deployed for treatment.However, when pulling the stent delivery system (sds) back into the guide catheter, the distal end of the sds would not go into the guide.The physician had to pull everything out and it was noticed that the balloon did not completely re-wrap at the distal tip of the stent delivery system.The procedure was completed and there were no patient complications nor injuries reported.It was further reported that resistance was only felt after the stent was properly deployed.The balloon was inflated on nominal pressure and was pulled back quickly.
Additional Manufacturer Narrative
(b5) updated describe event or problem device evaluated by mfr: a synergy ii.50 x 28mm stent delivery system was returned for analysis inside another manufacturers guidecatheter with the hemostatic valve and another manufacturers 0.014 guidewire attached.The stent was not returned as it was implanted during the procedure.The balloon was reviewed and identified that the distal balloon cone appeared to be bunched distally.The balloon was inflated to rated burst pressure of 16 atm, without issue and maintained pressure.The device was deflated successfully under 30seconds.The delivery system was removed proximally from the guide catheter without issue.A visual examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found the wire lumen bunched 137.6cm distal to the distal end of the strain relief and another manufactures guidewire was visibly stuck inside wire lumen.The port-bond appeared to be stretched.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: 11447104
• Report Number: 2134265-2021-02430
• Device Sequence Number: 19713623
• Product Code: NIQ
• UDI-Device Identifier: 08714729840305
• UDI-Public: 08714729840305
• 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
• Device Implanted Year: 2021
• 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): 04/12/2021

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: 08/12/2022
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0025898666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1