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

Model Number	10604
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodgement occurred.The physician attempted a stent procedure on a patient with a 90% lesion in a calcified and tortuous rca.The vessel was wired with the help of a non bsc microcatheter and non bsc wire.The wire was removed and replaced with a another wire.A 2.0 x 12 balloon was advanced and used to pre-dilate the lesion.A 3.0 x 24 synergy was attempted, but was unable to cross the lesion.A guidezilla ii extension catheter was advanced to the ostium of the rca, but unable to advance due to previously placed stent in the ostium.The 3.0 x 24 synergy was again attempted to cross.As the balloon catheter exited the guide it appeared the stent had become dislodged from the delivery system.The stent was located at the collar of the guidezilla ii.The guidezilla was removed and the stent successfully removed from the patient.A new guidezilla ii catheter was advanced.A new 3.0 x 24 synergy was attempted to advance.The second 3.0 x 24 synergy did not cross the lesion.Upon removal from the patient it was noticed the stent was not on the delivery system.Fluro confirmed the stent was at the end of the guidezilla ii.A 2.0 x 12 balloon was advanced through the un-deployed stent and inflated.The entire system was then removed from the patient successfully.Patient left the cath lab with no complications and a successful pci of the rca.
Event or Problem Description
It was reported that stent dislodgement occurred.The physician attempted a stent procedure on a patient with a 90% lesion in a calcified and tortuous rca.The vessel was wired with the help of a non bsc microcatheter and non bsc wire.The wire was removed and replaced with a another wire.A 2.0 x 12 balloon was advanced and used to pre-dilate the lesion.A 3.0 x 24 synergy was attempted, but was unable to cross the lesion.A guidezilla ii extension catheter was advanced to the ostium of the rca, but unable to advance due to previously placed stent in the ostium.The 3.0 x 24 synergy was again attempted to cross.As the balloon catheter exited the guide it appeared the stent had become dislodged from the delivery system.The stent was located at the collar of the guidezilla ii.The guidezilla was removed and the stent successfully removed from the patient.A new guidezilla ii catheter was advanced.A new 3.0 x 24 synergy was attempted to advance.The second 3.0 x 24 synergy did not cross the lesion.Upon removal from the patient it was noticed the stent was not on the delivery system.Fluro confirmed the stent was at the end of the guidezilla ii.A 2.0 x 12 balloon was advanced through the undeployed stent and inflated.The entire system was then removed from the patient successfully.Patient left the cath lab with no complications and a successful pci of the rca.It was further reported that the second stent was partially deployed to remove it from the body and the procedure was completed with the initial balloon.
Additional Manufacturer Narrative
Initial aware date corrected from 29/04/2019 to 26/04/2019.Updated describe event or problem.Device is a combination product.

• 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: 8613166
• Report Number: 2134265-2019-05315
• Device Sequence Number: 19388391
• Product Code: NIQ
• UDI-Device Identifier: 08714729840237
• UDI-Public: 08714729840237
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/06/2019

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: 02/13/2021
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0023391760
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR