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

Model Number	10604
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the stent found signs of stent damage.The 1st row of proximal stent struts were lifted and pulled in a distal direction.The 1st to 3rd distal stent struts rows were moved on the balloon profile in a proximal direction with the rest of the stent struts noted to be bunched towards the mid-section area of the stent.Due to the extent of the stent damage no accurate reading of the stent od could be taken.Proximal stent damage most likely occurred during withdrawal attempts while distal stent damage most likely occurred during advancing attempts trough the guide catheter.The balloon cones were reviewed, and no issues were noted.Crimp markings were visible on the exposed balloon wall from the 1st to the 3rd distal stent strut rows but balloon wings were observed to be tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed signs of damage on the distal end of the tip.Tip damage most likely occurred when the tip was pushed against a restriction.A visual and tactile examination of the hypotube found multiple kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force being applied on the delivery system.A visual and tactile examination of the shaft polymer extrusion found a kink in the shaft polymer extrusion measured using calibrated ruler at 137 cm distal from the distal end of strain relief.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 20 jul 2019.It was reported that the stent got caught and stuck on the guidezilla ll.A 4.00 x 24 synergy drug eluting stent was used for treatment.During procedure, the stent was tried to run through the 6f guidezilla ii catheter.However, the stent got caught and was stuck at the collar; whole system was then removed.Double wiring was performed and another stent was used.The procedure was completed with a different device.No complications reported and there were no patient injuries of any kind.However, device analysis revealed stent struts lifted.

• 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: 8794526
• Report Number: 2134265-2019-08079
• Device Sequence Number: 1978147
• Product Code: NIQ
• UDI-Device Identifier: 08714729840251
• UDI-Public: 08714729840251
• 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
• Report Date (Section B): 07/16/2019

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: 08/28/2020
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0022632059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/16/2019
• 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: GUIDE CATHETER- 6F GUIDEZILLA II