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

Model Number	H7493941832500
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: (b)(6).
Event or Problem Description
It was reported that the balloon almost detached.During a procedure involving a 5.00 x 32mm synergy xd it was noted that the balloon almost detached.No patient complications were reported.
Event or Problem Description
It was reported that the balloon almost detached.During a procedure involving a 5.00 x 32mm synergy xd it was noted that the balloon almost detached.No patient complications were reported.
Additional Manufacturer Narrative
B3 - date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: synergy xd 5.00 x 32mm stent delivery system was returned for analysis.The stent was not returned.The crimped stent outer diameter was measured and was within max crimped stent profile measurement.The balloon cones were reviewed via scope, and no issues were noted.The balloon returned deflated and the distal balloon cone appeared bunched.Clear dried media was visible inside the balloon.A visual and tactile examination of the hypotube found no issues.Examination of the tip via scope found no damage to the tip.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and a tactile examination was performed.The wire-port was stretched.The mid-shaft was stretched proximal to the wire-port and the shaft polymer extrusion was stretched distal to the wire-port.The inner wire lumen was damaged 143.3 cm distal to the distal end of strain relief.No other issues were identified during the product analysis.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11440434
• Report Number: 2134265-2021-02249
• Device Sequence Number: 11637119
• Product Code: NIQ
• UDI-Device Identifier: 08714729981299
• UDI-Public: 08714729981299
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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: 06/24/2022
• Device Model Number: H7493941832500
• Device Lot Number: 0025663506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1