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

Model Number	10606
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is a combination product.
Event or Problem Description
It was reported that stent damage and guidewire entrapment occurred.The target lesion was located in the left anterior descending artery.A 3.00 x 32 synergy drug-eluting stent and 300cm straight tip samurai guidewire was selected for use.During advancement, the delivery system got stuck on the guidewire.During attempts to remove the device from the wire, while still outside of the patient, the stent got damaged.The portion of the wire stuck with the delivery system, was cut off.The procedure was completed with a new synergy stent.There were no patient complications reported and the patient's status was great.
Event or Problem Description
It was reported that stent damage and guidewire entrapment occurred.The target lesion was located in the left anterior descending artery.A 3.00 x 32 synergy drug-eluting stent and 300cm straight tip samurai guidewire was selected for use.During advancement, the delivery system got stuck on the guidewire.During attempts to remove the device from the wire, while still outside of the patient, the stent got damaged.The portion of the wire stuck with the delivery system, was cut off.The procedure was completed with a new synergy stent.There were no patient complications reported and the patient's status was great.It was further reported that the shaft broke post procedure in an attempt to remove the guidewire.
Additional Manufacturer Narrative
This device is a combination product.D10 returned to manufacturer date corrected.A synergy ii us mr 3.00 x 32mm stent delivery system was returned for analysis in 2 pieces with a guidewire stuck in the wire lumen of the distal portion of the device.A visual and microscopic examination of the stent found proximal to mid-stent damage, with stent struts stretched and bunched.The undamaged stent od (outer diameter) was measured and the result is within maximum crimped stent profile measurement.The balloon cones were reviewed.No issues were noted with the distal balloon.The proximal balloon cone and the exposed proximal balloon wall were creased.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple hypotube kinks at several locations along the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found a shaft break located 126 mm distal to the mid-shaft/hypotube bond, with the corewire exposed at the break site.The outer shaft polymer extrusion was severely damaged (twisted and bunched) along the entire length of the shaft polymer extrusion.A recommended 0.0140 guidewire was returned with the device, but not attached to the device at any point.A portion of a 0.0160 guidewire was stuck in the wire lumen of the distal portion of the device.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: 9693695
• Report Number: 2134265-2020-01110
• Device Sequence Number: 19404079
• Product Code: NIQ
• UDI-Device Identifier: 08714729840350
• UDI-Public: 08714729840350
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/16/2020

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: 09/02/2021
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0024394204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: 300CM STRAIGHT TIP SAMURAI; GUIDEWIRE: 300CM STRAIGHT TIP SAMURAI