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

Model Number	10601
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in a coronary artery.After crossing the lesion with a guide wire, a 2.75x12mm synergy ii drug-eluting stent was advanced for treatment.However, while the device was being advanced, it became twisted with the wire.The physician was unable to advance the stent further over the wire.Both the wire and the stent were removed together.A new wire and a new stent were advanced and completed the procedure.No patient complications were reported and the patient's status was fine.
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in a coronary artery.After crossing the lesion with a guide wire, a 2.75x12mm synergy ii drug-eluting stent was advanced for treatment.However, while the device was being advanced, it became twisted with the wire.The physician was unable to advance the stent further over the wire.Both the wire and the stent were removed together.A new wire and a new stent were advanced and completed the procedure.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device is a combination product.Date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: synergy ii us mr 2.75 x 12mm stent delivery system was returned for analysis.Device was returned attached to a guidewire, and the guidewire can not be removed from the synergy device.The guidewire was bunched and stretched distal to distal tip of the synergy device.Guidewire outer diameter was measured.A visual examination of the stent found proximal stent damage on proximal stent strut row 1.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 and microscopic examination of the bumper tip found distal tip 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 shaft polymer extrusion inner lumen damage located 137.5cm distal to distal strain relief.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: 8586994
• Report Number: 2134265-2019-04749
• Device Sequence Number: 19381047
• Product Code: NIQ
• UDI-Device Identifier: 08714729840046
• UDI-Public: 08714729840046
• 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): 06/13/2019

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: 11/12/2020
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0022989742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1