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

Lot Number	0030886349
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that the stent was under expanded and the patient died.The patient presented in critical, unstable condition and was on support.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified proximal left anterior descending (lad) artery.After plain old balloon angioplasty (poba) was performed with a 2.0 balloon in the totally occluded lad, flow was partially restored.A 3.00 x 24mm synergy xd drug-eluting stent (des) was advanced for treatment.However, it appeared that the stent was extremely under expanded.This prevented the 2.50 x 24mm synergy xd and 2.50 x 12mm synergy xd stents from crossing the placed stent for distal placement in the lad.The physician was unable to re-establish flow to the totally occluded lad.The patient deteriorated quickly and died on the table.
Additional Manufacturer Narrative
Device evaluated by mfr.Synergy xd mr us 3.00 x 24mm stent delivery system was returned for analysis.Visual, tactile, microscopic, and dimensional analysis was performed on the device.Visual and tactile inspection noted multiple kinks along the hyptoube shaft.There were no issues identified with the outer / mid-shaft sections or the inner lumen of the device.Microscopic analysis revealed there was no sign of damage, stretching or lifting of the stent struts.There were no signs of movement, the stent was set between the proximal and distal markerbands.The bumper tip showed no signs of distal tip damage.Dimenesional testing of the crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that the stent was under expanded and the patient died.The patient presented in critical, unstable condition and was on support.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified proximal left anterior descending (lad) artery.After plain old balloon angioplasty (poba) was performed with a 2.0 balloon in the totally occluded lad, flow was partially restored.A 3.00 x 24mm synergy xd drug-eluting stent (des) was advanced for treatment.However, it appeared that the stent was extremely under expanded.This prevented the 2.50 x 24mm synergy xd and 2.50 x 12mm synergy xd stents from crossing the placed stent for distal placement in the lad.The physician was unable to re-establish flow to the totally occluded lad.The patient deteriorated quickly and died on the table.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18287855
• Report Number: 2124215-2023-65821
• Device Sequence Number: 6696270
• Product Code: NIQ
• UDI-Device Identifier: 08714729980988
• UDI-Public: 08714729980988
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 01/12/2024

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: 01/10/2025
• Device Lot Number: 0030886349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• 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: Death
• Patient Sex: Unknown