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

Lot Number	0033412498
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Vascular Dissection (3160); Embolism/Embolus (4438); Reduced Blood Flow (4598)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties occurred.The target lesion was located in the proximal first obtuse marginal (om).A 2.75 x 38mm synergy xd drug-eluting stent was advanced for treatment and deployed with no issues.However, when the stent delivery system (sds) balloon was fully deflated, it remained stuck in the stent.Multiple pulls and multiple inflations and deflations ensued without success, and a failed attempt was made to try and get a second wire past the stent.A hard pull was made to the sds catheter at which time the shaft broke.The proximal half was retrieved, but the distal half remained stuck in the stent.The catheter tip embolized in the vessel and the doctor opted to jail the tip into the om with another stent, effectively shutting down the om.The balloon being stuck and the forced needed to remove it caused a non-flow limiting dissection in the ostium of the om.The patient was admitted to the hospital beyond standard of care and treated with heavy anticoagulation and observation.The patient was stable following the procedure and later discharged.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 2.75 x 38mm was returned for analysis.A visual and tactile and microscopic examination identified no kinks or damages along the entire length of the hypotube.A visual and tactile examination of the distal extrusion identified a break in the midshaft at 8cm from the end tab of the laser cut section.The distal section of the break including the inner and outer distal extrusions, the balloon and tip section of the device was not returned for analysis.Microscopic inspection of the break site revealed the midshaft extrusion was stretched.
Event or Problem Description
It was reported that removal difficulties occurred.The target lesion was located in the proximal first obtuse marginal (om).A 2.75 x 38mm synergy xd drug-eluting stent was advanced for treatment and deployed with no issues.However, when the stent delivery system (sds) balloon was fully deflated, it remained stuck in the stent.Multiple pulls and multiple inflations and deflations ensued without success, and a failed attempt was made to try and get a second wire past the stent.A hard pull was made to the sds catheter at which time the shaft broke.The proximal half was retrieved, but the distal half remained stuck in the stent.The catheter tip embolized in the vessel and the doctor opted to jail the tip into the om with another stent, effectively shutting down the om.The balloon being stuck and the forced needed to remove it caused a non-flow limiting dissection in the ostium of the om.The patient was admitted to the hospital beyond standard of care and treated with heavy anticoagulation and observation.The patient was stable following the procedure and later discharged.

• 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: 20499920
• Report Number: 2124215-2024-65177
• Device Sequence Number: 7368836
• Product Code: NIQ
• UDI-Device Identifier: 08714729980933
• UDI-Public: 08714729980933
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/12/2024

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: 01/21/2026
• Device Lot Number: 0033412498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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; Hospitalization
• Patient Sex: Unknown