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

Model Number	10601
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that the stent was stuck on the wire.A 2.75x12 synergy drug eluting stent and a rotawire were used in a percutaneous coronary intervention (pci).During the procedure, ablation was completed using rotapro in a challenging lesion and pre-dilation was then performed using two non- bsc balloons.Subsequently, stenting was desired and a synergy stent was loaded into the rotawire.However, the stent became stuck on the wire.Extreme manipulation and excessive force was required to remove the stent from the wire.The procedure was completed with a different device.No complications reported and the patient was not harmed.
Additional Manufacturer Narrative
Device is a combination product.The device was returned for analysis.An examination (visual and via scope) of the crimped stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The balloon was 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 tactile examination of the hypotube identified multiple hypotube kinks.An examination (visual and via scope) of the shaft polymer extrusion fount that the outer shaft polymer extrusion was kinked and that the inner polymer extrusion was stretched and twisted at multiple locations.An examination (visual and via scope) of the tip identified tip damage.An attempt was made to load the device onto a 0.014 guidewire, however it failed to load due to inner lumen damage.The dimensional inspection revealed that the outer diameter (od) of the crimped stent was within specification.
Event or Problem Description
It was reported that the stent was stuck on the wire.A 2.75x12 synergy drug eluting stent and a rotawire were used in a percutaneous coronary intervention (pci).During the procedure, ablation was completed using rotapro in a challenging lesion and pre-dilation was then performed using two non- bsc balloons.Subsequently, stenting was desired and a synergy stent was loaded into the rotawire.However, the stent became stuck on the wire.Extreme manipulation and excessive force was required to remove the stent from the wire.The procedure was completed with a different device.No complications reported and the patient was not harmed.

• 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: 8882973
• Report Number: 2134265-2019-09493
• Device Sequence Number: 19432309
• Product Code: NIQ
• UDI-Device Identifier: 08714729840046
• UDI-Public: 08714729840046
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/30/2019

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: 02/10/2021
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0023387992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 09/30/2019
• 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: BALLOON- ABBOTT TREK; BALLOON- ABBOTT TREK; BALLOON- ABBOTT TREK