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

Model Number	10607
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/27/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported via voluntary medwatch # (b)(4) that the patient died.Prior to the procedure the patient was at a rehab facility were she was experiencing nausea and vomiting, which later on developed heaviness of arms and chest.An ambulance was called and the patient was transferred to the hospital.During cardiac catheterization, a 3.50 x 38 synergy drug-eluting stent was deployed in the left anterior descending artery (lad).Post-deployment, the wire was able to be removed; however, the delivery balloon was stuck in the in-stent restenosis of the previously deployed stent in the proximal lad which likely under expanded.A new wire was attempted to be advanced but could not pass the balloon which was in the lad.The physician pulled the delivery balloon hard and the shaft broke with balloon still stuck in the lad stent.The patient had a pulseless electrical activity (pea) arrest and a long samurai wire was used and formed a snare through the guide catheter to retrieved the stuck balloon and its shaft.No fragments were left inside the body afterwards.However, the patient coded and was unable to be resuscitated.The patient died.Suspected cause of death was myocardial infarction.Autopsy as not done.
Additional Manufacturer Narrative
Device is a combination product.The synergy device was not returned for analysis.The site provided a device photo which revealed that the shaft polymer extrusion was severely damaged, stretched and broken.Brownish media resembling blood was observed inside the balloon body and on the shaft polymer extrusion shaft.The balloon appeared to be torn longitudinally.
Event or Problem Description
It was reported via voluntary medwatch # (b)(4) that the patient died.Prior to the procedure the patient was at a rehab facility were she was experiencing nausea and vomiting, which later on developed heaviness of arms and chest.An ambulance was called and the patient was transferred to the hospital.During cardiac catheterization, a 3.50 x 38 synergy drug-eluting stent was deployed in the left anterior descending artery (lad).Post-deployment, the wire was able to be removed; however, the delivery balloon was stuck in the in-stent restenosis of the previously deployed stent in the proximal lad which likely under expanded.A new wire was attempted to be advanced but could not pass the balloon which was in the lad.The physician pulled the delivery balloon hard and the shaft broke with balloon still stuck in the lad stent.The patient had a pulseless electrical activity (pea) arrest and a long samurai wire was used and formed a snare through the guide catheter to retrieved the stuck balloon and its shaft.No fragments were left inside the body afterwards.However, the patient coded and was unable to be resuscitated.The patient died.Suspected cause of death was myocardial infarction.Autopsy as not done.

• 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: 9569316
• Report Number: 2134265-2019-16563
• Device Sequence Number: 19586272
• Product Code: NIQ
• UDI-Device Identifier: 08714729840428
• UDI-Public: 08714729840428
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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: 09/02/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0024425786
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/12/2020
• 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: 77 YR
• Patient Weight: 56