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

Model Number	10605
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: the event date was note reported but it was reported it occurred less than a month ago.The first date of the may was entered as an estimate.
Event or Problem Description
It was reported that stent obstruction and heart failure occurred.On (b)(6) 2020, two 4.00 x 28 synergy ii drug-eluting stents were implanted in the left anterior descending artery (lad).Less than a month ago, the patient was very sick and visited the hospital to check on the stents.It was noted that both stents had collapsed and the patient was in full congestive heart failure.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14917359
• Report Number: 2134265-2022-07514
• Device Sequence Number: 12334693
• Product Code: NIQ
• UDI-Device Identifier: 08714729840312
• UDI-Public: 08714729840312
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/05/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2021
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0024594407
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Female