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

Model Number	10607
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(6).
Event or Problem Description
It was reported that catheter entrapment, stent dislodgment occurred and patient died.A 2.50 x 38mm synergy drug-eluting stent was advanced, through a non bsc microcatheter, to treat a dissection, but failed to cross the lesion.During removal the synergy stent got caught on the microcatheter and collapsed the stent and pinched it on the wire and completely removed.The procedure was completed with another of the same device.The patient was unstable after the procedure and later died.
Additional Manufacturer Narrative
Device is a combination product.Initial reporter address 1: (b)(6).Device evaluated by mfr.A stent was returned on a guidewire.The stent delivery system (sds) was not returned for analysis.Damage was noted along the entire length of stent.A dried red/brown blood like substance was noted on the stent.The guidewire was measured and the outer diameter measured 0.014.
Event or Problem Description
It was reported that catheter entrapment, stent dislodgment occurred and patient died.A 2.50 x 38mm synergy drug-eluting stent was advanced, through a non bsc microcatheter, to treat a dissection, but failed to cross the lesion.During removal the synergy stent got caught on the microcatheter and collapsed the stent and pinched it on the wire and completely removed.The procedure was completed with another of the same device.The patient was unstable after the procedure and later died.

• 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: 8824871
• Report Number: 2134265-2019-08695
• Device Sequence Number: 2540991
• Product Code: NIQ
• UDI-Device Identifier: 08714729840398
• UDI-Public: 08714729840398
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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 Expiration Date: 04/14/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0023668878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: GLADIUS MONGO WIRE; GUIDEWIRE: GLADIUS MONGO WIRE; GUIDEWIRE: GLADIUS MONGO WIRE
• Outcome Attributed to Adverse Event: Death