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

Model Number	H7493941828250
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.A percutaneous coronary intervention was being performed.Vascular access was obtained via the right femoral artery.The target lesion was located in the non-tortuous and non-calcified circumflex artery and obtuse marginal artery.Predilation was performed with a 2.5x12mm emerge balloon catheter.A 3.50 x 32mm synergy xd drug-eluting stent was advanced and deployed in the proximal circumflex artery for 14 seconds at 11 atm.However, during procedure, the stent dislodged and migrated to the aorta.The stent was removed via snare.An emerge 1.5x12mm balloon catheter was inflated for 29 seconds at 14 atm in the first obtuse marginal.Subsequently, a 2.50x28mm a synergy xd drug-eluting stent was advanced for treatment.However, during procedure, the stent was dislodged.The stent was removed via snare.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluation by mfr: synergy xd mr us 2.50 x 28mm stent was returned for analysis without the crimped stent.A visual and microscopic examination of the balloon found no evidence of any positive pressure having been applied to the balloon.There were stent crimp marks visible on the balloon material.An examination of the distal extrusion found inner/wire lumen damage (bunching) noted at approx.16.5 cm distal to the guidewire port.A 0.014" guidewire could not be loaded and the device could not be inserted to test for tracking difficulties through a 5f guide catheter due to the inner/wire lumen damage.A visual and microscopic examination of the hypotube identified multiple kinking along the length of the hypotube.As the stent was not returned with the device a review was performed into the manufacturing stent crimp data for this batch.The crimped stent od (outer diameter) was measured at manufacture.The maximum and minimum value for the max crimped stent profile was 0.0398" and 0.033" respectively, and these values are within maximum crimped stent profile measurement.
Event or Problem Description
It was reported that stent dislodgement occurred.A percutaneous coronary intervention was being performed.Vascular access was obtained via the right femoral artery.The target lesion was located in the non-tortuous and non-calcified circumflex artery and obtuse marginal artery.Predilation was performed with a 2.5x12mm emerge balloon catheter.A 3.50 x 32mm synergy xd drug-eluting stent was advanced and deployed in the proximal circumflex artery for 14 seconds at 11 atm.However, during procedure, the stent dislodged and migrated to the aorta.The stent was removed via snare.An emerge 1.5x12mm balloon catheter was inflated for 29 seconds at 14 atm in the first obtuse marginal.Subsequently, a 2.50x28mm a synergy xd drug-eluting stent was advanced for treatment.However, during procedure, the stent was dislodged.The stent was removed via snare.The procedure was completed with a different device.There were no patient complications nor injuries reported.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12577008
• Report Number: 2134265-2021-12456
• Device Sequence Number: 11593664
• Product Code: NIQ
• UDI-Device Identifier: 08714729980834
• UDI-Public: 08714729980834
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

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: 03/29/2023
• Device Model Number: H7493941828250
• Device Lot Number: 0027107545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Race: White