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

Model Number	H7493941820220
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty was encountered.The target lesion was located in the mildly tortuous left anterior descending artery.After pre-dilation, a 2.25 x 20mm synergy xd drug-eluting stent was advanced for treatment.The device was inflated and the stent was expanded at 11 atmospheres.When the stent was expanded, the indeflator was released to deflate the balloon.However, it was noticed that the balloon did not deflate.Several attempts were made to reinflate and deflate the balloon as to try to release the balloon from the stent.The doctor rotated and pulled the catheter in an attempt to dislodge the balloon from the stent with success.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a synergy xd mr us 2.25 x 20mm stent delivery system was returned for analysis without the stent and with a stopcock valve attached to the manifold.Stent was not returned as it was positioned and deployed at the lesion site.The balloon cones were reviewed, and the balloon appeared in a partially inflated state with clear hard liquid noted inside and crimp markings evident on the balloon wall.The balloon folds were partially opened and not fully flattened.A visual and microscopic examination of the bumper tip showed distal tip damage.A visual and tactile examination of the hypotube found no issues.The manifold and hub visual examination found no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.The device was placed in water bath overnight for soaking pre-inflation test due dried liquid inside.Following soaking, the device was loaded onto a 0.014" guide wire and loaded into a test guide catheter without issue.The balloon was inflated with no issues and balloon folds clearly flattened following test deflation.Vacuum was pulled and the balloon deflated in 08 seconds with no issues.The encore inflation device was verified before and after use.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that removal difficulty was encountered.The target lesion was located in the mildly tortuous left anterior descending artery.After pre-dilation, a 2.25 x 20mm synergy xd drug-eluting stent was advanced for treatment.The device was inflated and the stent was expanded at 11 atmospheres.When the stent was expanded, the indeflator was released to deflate the balloon.However, it was noticed that the balloon did not deflate.Several attempts were made to reinflate and deflate the balloon as to try to release the balloon from the stent.The doctor rotated and pulled the catheter in an attempt to dislodge the balloon from the stent with success.No patient complications were 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
• MDR Report Key: 11163720
• Report Number: 2134265-2021-00116
• Device Sequence Number: 19043979
• Product Code: NIQ
• UDI-Device Identifier: 08714729980735
• UDI-Public: 08714729980735
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2022
• Device Model Number: H7493941820220
• Device Lot Number: 0025600473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1