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

Model Number	10607
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break and removal difficulty occurred.A 3.00 x 38 synergy drug-eluting stent was selected for left heart catheterization.The stent was deployed; however, as the stent delivery system was being removed, the balloon got stuck on the guidewire and was stretched.The guidewire and stent delivery system were removed together with no harm to the patient.The procedure was completed with the original device.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that shaft break and removal difficulty occurred.A 3.00 x 38 synergy drug-eluting stent was selected for left heart catheterization.The stent was deployed; however, as the the stent delivery system was being removed, the balloon got stuck on the guidewire and was stretched.The guidewire and stent delivery system were removed together with no harm to the patient.The procedure was completed with the original device.No patient complications nor injuries were reported.It was further reported that the target lesion had over 90% stenosis and was located in a non-tortuous and non-calcified artery.The lesion was also predilated, however, the stenosis was roughly the same following predilatation.
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break and removal difficulty occurred.The target lesion has over 90% stenosis.A 3.00 x 38 synergy drug-eluting stent was selected for left heart catheterization.Following predilatation, the stent was deployed.However, as the the stent delivery system was being removed, the balloon got stuck on the guidewire and was stretched.The guidewire and stent delivery system were removed together with no harm to patient.The procedure was completed with the original device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluation by mfr: synergy ii us mr 3.00 x 38mm stent delivery system was returned for analysis.The device was returned without the stent.The balloon was reviewed, and issues were noted.No stent was attached to the balloon and the balloon appeared to be in a deflated state with a blood like substance in the balloon.A visual and microscopic examination of the bumper tip showed no signs of damage.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 a break in the polymer extrusion 35.3cm proximal to the distal end of the distal tip, which is the the exchange port location, exposing the core wire.Damage was also noted at points all along the shaft polymer extrusion in the form of multiple kinks and stretching.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: 10169393
• Report Number: 2134265-2020-07169
• Device Sequence Number: 11298373
• Product Code: NIQ
• UDI-Device Identifier: 08714729840411
• UDI-Public: 08714729840411
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2020

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: 12/18/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0024977493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 06/29/2020; 07/20/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/15/2020; 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR