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

Model Number	10602
Medical Device Problem Codes	Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent was dislodged upon removal of the delivery system.The target lesion was in the severely tortuous and calcified proximal, mid and distal right coronary artery.A 4.00x28 and 4.00x16 synergy drug eluting stent were used for treatment together with the guidezilla guide extension catheter.During the procedure, two synergy stents were deployed in the vessel and a non-bsc stent was used distal to the two synergy.Subsequently, the 4.00x28 stent was placed into the vessel but could not advance to the distal lesion.The stent was removed from the body and it was noted to be unraveled.Then, a 4.0x16 stent was advanced in the guidezilla however it could not pass the transition part of the guidezilla.The stent delivery system was able to be removed but the stent was stuck in the shaft of the co-pilot tuohy.The procedure was completed with a different device.No complications were reported and there was no harm to the patient.
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent was dislodged upon removal of the delivery system.The target lesion was in the severely tortuous and calcified proximal, mid and distal right coronary artery.A 4.00x28 and 4.00x16 synergy drug eluting stent were used for treatment together with the guidezilla guide extension catheter.During the procedure, two synergy stents were deployed in the vessel and a non-bsc stent was used distal to the two synergy.Subsequently, the 4.00x28 stent was placed into the vessel but could not advance to the distal lesion.The stent was removed from the body and it was noted to be unraveled.Then, a 4.0x16 stent was advanced in the guidezilla however it could not pass the transition part of the guidezilla.The stent delivery system was able to be removed but the stent was stuck in the shaft of the co-pilot tuohy.The procedure was completed with a different device.No complications were reported and there was no harm to the patient.It was further reported that there was resistance on both issues.The first synergy would not pass through the newly deployed two synergy stents as it may have been getting caught on the other struts.The other synergy stent would not pass through the collar of the guidezilla.There was no problem noted with the guidezilla during advancement and removal.

• 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: 10135412
• Report Number: 2134265-2020-07554
• Device Sequence Number: 14416143
• Product Code: NIQ
• UDI-Device Identifier: 08714729840138
• UDI-Public: 08714729840138
• 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): 07/14/2020

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: 08/28/2020
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0022618540
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1