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

Model Number	10603
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Death (1802)
Date of Event	07/24/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that the patient died.A 2.75 x 20 synergy drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with a non-bsc balloon catheter to get into the undeployed stent and inflate it.However, after the procedure, the patient died.
Event or Problem Description
It was reported, that the patient died.A 2.75 x 20 synergy drug-eluting stent was advanced, but failed to cross the lesion.The procedure was completed with a non-bsc balloon catheter to get into the undeployed stent, and inflate it.However, after the procedure, the patient died.It was further reported, that the stent was dislodged from its balloon.The dislodged stent could not be snared, so the stent was deployed using the non-bsc balloon catheter.
Additional Manufacturer Narrative
(b5) describe event or problem: updated.(d6) implant date: updated.(f10 and h6) device codes: updated.

• 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: 10482434
• Report Number: 2134265-2020-11198
• Device Sequence Number: 3394965
• Product Code: NIQ
• UDI-Device Identifier: 08714729840169
• UDI-Public: 08714729840169
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/20/2021
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0024704250
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 55 YR