MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number	H7493926038350
Health Effect - Clinical Codes	Cardiopulmonary Arrest (1765); Death (1802)
Date of Event	11/27/2019
Type of Reportable Event	Death
Event or Problem Description
An elderly female patient with history of hypertension (htn), chest pain, recent traffic accident with t12 compression fracture and right (r) sided rib fractures presents to the hospital.While having a cardiac catheterization, the stent deployed in the left anterior descending (lad) artery.Unable to remove delivery balloon/ catheter.While attempting to remove, balloon tip fractured.Attempts made to snare and remove balloon.Pt coded.Balloon eventually retrieved.Unable to resuscitate patient expired.Procedure: cardiac cath."we were able to take the wire out but not the balloon which was stuck in the sever instant restenosis of the proximal left anterior (la) stent which is likely under expanded.I tried to use another coronary wire but could not pass by the balloon which was in the lad.We pulled the balloon hard and shaft broke with balloon still stuck in the lad stent.Patient had a pulseless electrical activity (pea) arrest and we took long sumariai wire and formed a snare through guide catheter to retrieve the stuck balloon and its shaft.There was no residual material were left in place afterwards.".

• Brand Name: SYNERGY
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9457971
• Report Number: 9457971
• Device Sequence Number: 3078549
• Product Code: NIQ
• UDI-Device Identifier: 08714729840428
• UDI-Public: (01)08714729840428(17)210902(10)24425786
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/04/2019
• Report Date (Section F): 12/04/2019

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 Model Number: H7493926038350
• Device Catalogue Number: H7493926038350
• Device Lot Number: 24425786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2019
• 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 Weight: 56
• Date Report Sent to FDA: 12/04/2019