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

Model Number	10619
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that the stent moved on the balloon.During unpacking of a 4.50 x 20 synergy drug-eluting stent, it was noted that the stent had shifted on the delivery catheter.The catheter never entered the patient's body and the patient was successfully treated with another of the same device.There were no complications reported.
Additional Manufacturer Narrative
Device is a combination product.Initial reporter facility name updated from (b)(6) - (b)(6) hospital.Initial reporter address 1 updated from (b)(6) to (b)(6).Initial reporter city updated from (b)(6) to (b)(6).Initial reporter phone updated from (b)(6) to (b)(6).
Event or Problem Description
It was reported that the stent moved on the balloon.During unpacking of a 4.50 x 20 synergy drug-eluting stent, it was noted that the stent had shifted on the delivery catheter.The catheter never entered the patient's body and the patient was successfully treated with another of the same device.There were no complications reported.

• 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: 8629678
• Report Number: 2134265-2019-05554
• Device Sequence Number: 19243555
• Product Code: NIQ
• UDI-Device Identifier: 08714729973362
• UDI-Public: 08714729973362
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P150003/S039
• 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): 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2020
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0022914482
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1