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

Model Number H7493926016250

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Facial Nerve Paralysis (1846); Stenosis (2263); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 08/01/2018

Event Type  malfunction  

Event Description

Stent dislodged from stent balloon, never deployed.Patient was taken to cath lab where bypass angiogram revealed an occluded lima-lad, patent svg to om and rca, patient received a des to lad.Per operative report: a 3rd drug-eluting stent (2.5x16mm) was attempted to advance distal to the first stent to fix the distal lad lesion, but stent was hung up on the struts of the proximal stents and could not be advanced and it was pulled out of the body.On inspection of the device, the stent was not seen on the balloon after coming out.A thorough search of the patient was performed with fluoroscopy; the bed and floor were also searched but the stent could not be located.It was not seen anywhere inside the body.Patient experienced alteration of mental status and code stroke was called.Patient had transient alteration in mental status after the procedure, as evidenced by facial twitching and dysarthria.Ct angiogram of the head and neck revealed no hemodynamically significant stenosis of the internal carotids.Discussed with neurosurgery.As there is no flow limitation and no evidence of clot or thrombus, anticoagulation would be the best strategy.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7771788
• MDR Text Key: 116729629
• Report Number: 7771788
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840091
• UDI-Public: (01)08714729840091(17)200515(10)22161433
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/06/2018,08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493926016250
• Device Catalogue Number: H7493926016250
• Device Lot Number: 22161433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23360 DA
• Patient Weight: 95