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

Model Number	10601
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 4.00 x 12mm stent delivery system (sds) was returned for analysis with distal region of the device including shaft polymer extrusion balloon and tip caught in a snare and inside a 7f guidecatheter.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 no issues.A visual examination of the outer and inner lumen and mid-shaft section found a break in the polymer extrusion 120cm distal to the distal end of the strain relief, with multiple kinks along the length of the shaft polymer extrusion.Additionally, a 2 cm section of the shaft polymer extrusion was stretched at the guidewire echange port.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.
Event or Problem Description
Reportable based on device analysis completed on 23-sep-2020.It was reported that damaged device occurred.A 4.00 x 12 synergy drug-eluting stent was selected for use.However, during procedure, the device was found defective.The procedure was completed and there were no patient complications reported.However, returned device analysis revealed shaft polymer extrusion detached/separated and stent detached/separated.

• 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: 10661765
• Report Number: 2134265-2020-13477
• Device Sequence Number: 4283804
• Product Code: NIQ
• UDI-Device Identifier: 08714729840077
• UDI-Public: 08714729840077
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2020

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: 08/18/2021
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0024326846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1