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

Model Number	H7493941838270
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 2.75 x 38mm synergy xd drug-eluting stent was introduced during a procedure, but felt sticky and failed to rack over the wire within the guide catheter.The device was removed along with the wire.A kink was noted in the mid proximal section and the distal end looked broken and frayed.The wire was wiped down and the procedure completed with another stent.There were no patient effects.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 2.75 x 38mm stent delivery system (sds) was returned for analysis in two sections and the distal shaft was attached to the customer's 0.014 inch guidewire.Examination of the crimped stent via scope found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent outer diameter was within max crimped stent profile measurement.The balloon cones were reviewed via scope, and no issues were noted.The balloon wings were tightly wrapped and evenly folded.The balloon had not been subjected to positive pressure.A visual and tactile examination of the hypotube found multiple kinks.Examination of the tip via scope found 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.A mid-shaft break was noted 121.8cm distal to the distal end of strain relief.The inner wire lumen was damaged 3.8cm proximal to the proximal balloon markerband.The distal section of the device could not be tracked on a test guidewire due to the inner shaft stretching.The proximal section of the sds was introduced through a 5f test guidecatheter without issue.Unable to remove the customer guidewire due to the inner damage.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred.A 2.75 x 38mm synergy xd drug-eluting stent was introduced during a procedure, but felt sticky and failed to rack over the wire within the guide catheter.The device was removed along with the wire.A kink was noted in the mid proximal section and the distal end looked broken and frayed.The wire was wiped down and the procedure completed with another stent.There were no patient effects.

• 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: 11476355
• Report Number: 2134265-2021-02543
• Device Sequence Number: 17124804
• Product Code: NIQ
• UDI-Device Identifier: 08714729980933
• UDI-Public: 08714729980933
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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: 12/01/2022
• Device Model Number: H7493941838270
• Device Lot Number: 0026541444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1