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

Model Number	H7493941824400
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement and shaft break occurred.The target lesion was located in an angulated right coronary artery with a recently placed stent in situ.After a 6fr guidezilla ii was in position, a 4.00 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the stent came off the balloon and broke halfway out of the guidezilla.Snare was used in addition to passing a balloon distal and pulling piece of stent to the ostium, where it was snared again and removed from the patient's body.There was significant delay in case, but no harm to patient.The procedure was aborted.There were no further complications reported.
Event or Problem Description
It was reported that stent dislodgement and shaft break occurred.The target lesion was located in an angulated right coronary artery with a recently placed stent in situ.After a 6fr guidezilla ii was in position, a 4.00 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the stent came off the balloon and broke halfway out of the guidezilla.Snare was used in addition to passing a balloon distal and pulling piece of stent to the ostium, where it was snared again and removed from the patient's body.There was significant delay in case, but no harm to patient.The procedure was aborted.There were no further complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the synergy xd mr us 4.00 x 24mm stent delivery system was returned for analysis.A visual examination of the stent found the stent detached from the delivery system and the entire stent was damaged/stretched.Two connectors were visible on the distal end of the stent, the proximal stent was entirely damaged.The crimped stent outer diameter measured at manufacture and was within maximum crimped stent profile measurement.The balloon cones were reviewed, and it appeared that the proximal balloon cone was bunched.A visual and microscopic examination of the bumper tip showed signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found a mid-shaft break located 124.7cm distal to distal end of the strain relief with the core wire exposed.The mid-shaft and shaft polymer extrusion were stretched at either side of the break sites.A blood-like substance was visible inside the inflation lumen.The inner wire lumen was damaged/stretched at multiple locations.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: 12215499
• Report Number: 2134265-2021-09268
• Device Sequence Number: 4301497
• Product Code: NIQ
• UDI-Device Identifier: 08714729981145
• UDI-Public: 08714729981145
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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: 03/01/2023
• Device Model Number: H7493941824400
• Device Lot Number: 0026944756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 09/14/2021
• 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: GUIDEZILLA II; GUIDEZILLA II; GUIDEZILLA II
• Outcome Attributed to Adverse Event: Required Intervention