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

Lot Number	0031225210
Medical Device Problem Codes	Break (1069); Inflation Problem (1310)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that a shaft break occurred, the device was unretrieved requiring additional surgery.The 70% stenosed target lesion was located in the mildly tortuous and moderately to severely calcified left anterior descending artery (lad).A 2.50 x 48mm synergy xd drug eluting stent was advanced for treatment together with a non-bsc guide catheter.However, upon inserting the second 2.5 x 48mm synergy, the physician was using a non-bsc guide catheter to help advance the stents, it was noted the second stent was not positioned as expected.Upon repositioning, the stent was successfully deployed.However, it was noted the balloon was not inflating.A second indeflator was opened and upon trying to deploy the stent again, it was noted the balloon was not inflating and blood was coming back into the indeflator.Fluoroscopy confirmed the stent was not deployed and the non-bsc guide catheter was advanced over the proximal portion of the stent to retrieve.Upon trying to retrieve the stent, the hypotube and shaft broke leaving the stent deployment system with balloon in the patients lad.It was not attempted to snare the system out, instead it was left in the patient and transferal of the patient emergently to another facility for emergent open heart surgery occurred.
Event or Problem Description
It was reported that a shaft break occurred, the device was unretrieved requiring additional surgery.The 70% stenosed target lesion was located in the mildly tortuous and moderately to severely calcified left anterior descending artery (lad).A 2.50 x 48mm synergy xd drug eluting stent was advanced for treatment together with a non-bsc guide catheter.However, upon inserting the second 2.5 x 48mm synergy, the physician was using a non-bsc guide catheter to help advance the stents, it was noted the second stent was not positioned as expected.Upon repositioning, the stent was successfully deployed.However, it was noted the balloon was not inflating.A second indeflator was opened and upon trying to deploy the stent again, it was noted the balloon was not inflating and blood was coming back into the indeflator.Fluoroscopy confirmed the stent was not deployed and the non-bsc guide catheter was advanced over the proximal portion of the stent to retrieve.Upon trying to retrieve the stent, the hypotube and shaft broke leaving the stent deployment system with balloon in the patients lad.It was not attempted to snare the system out, instead it was left in the patient and transferal of the patient emergently to another facility for emergent open heart surgery occurred.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: synergy xd mr us 2.50 x 48mm was returned for analysis.A visual and tactile examination identified no kinks along the hypotube.A visual examination of the distal extrusion identified a break in the midshaft extrusion.The break was located at 117.7cm distal to the distal end of the strain relief.The distal section of the break including the distal extrusion, balloon and tip sections of the device was not returned for analysis.A microscopic examination identified a break in the lasercut region.The break was contained in a section of the midshaft extrusion.

• 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: 18763746
• Report Number: 2124215-2024-06307
• Device Sequence Number: 4387787
• Product Code: NIQ
• UDI-Device Identifier: 08714729985204
• UDI-Public: 08714729985204
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 05/08/2024

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: 03/05/2025
• Device Lot Number: 0031225210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Race: White