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

Model Number	H7493941812300
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that distal shaft separation occurred.The target lesion was located in the proximal left anterior descending artery.A 3.00 x 12mm synergy xd drug-eluting stent was advanced for treatment.The balloon was inflated at 6 atmospheres when it was noted that blood was going back into the inflation device.The delivery system was removed from the guide catheter, but noted that the delivery balloon had disconnected from the shaft and remained inside the patient's body.The physician was able to deliver several emerge balloon catheters to crush the stent and balloon.A 3.50 x 16mm synergy xd stent was placed to jail the initial stent and balloon against the vessel wall.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
A synergy xd mr us 3.00 x 12mm stent delivery system was returned for analysis without the distal shaft including the balloon and stent portion.The partial device (125cm in length) from proximal tip of manifold to guidewire port with corewire exposed was returned.A visual and tactile examination of the hypotube found multiple kinks along several locations of the hypotube shaft.A fracture was noted at the hypotube laser cut region 107.5cm distally from distal end of the strain relief.The break appeared at the second spiral of the laser cut held together by the corewire.The outer shaft polymer extrusion was separated at the fracture site also with the shaft polymer extrusion not present on the distal lasercut region.A visual examination of the outer and inner lumen and mid-shaft section identified a break in the polymer extrusion region (within the trough/wire exchange port with exposed corewire) 125cm distal to tip of the manifold.The corewire was also exposed (extending 2.8cm distal to hypotube tab).No other issues were identified during the product analysis.
Event or Problem Description
It was reported that distal shaft separation occurred.The target lesion was located in the proximal left anterior descending artery.A 3.00 x 12mm synergy xd drug-eluting stent was advanced for treatment.The balloon was inflated at 6 atmospheres when it was noted that blood was going back into the inflation device.The delivery system was removed from the guide catheter, but noted that the delivery balloon had disconnected from the shaft and remained inside the patient's body.The physician was able to deliver several emerge balloon catheters to crush the stent and balloon.A 3.50 x 16mm synergy xd stent was placed to jail the initial stent and balloon against the vessel wall.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Bsc aware date was on 30nov2020.
Event or Problem Description
It was reported that distal shaft separation occurred.The target lesion was located in the proximal left anterior descending artery.A 3.00 x 12mm synergy xd drug-eluting stent was advanced for treatment.The balloon was inflated at 6 atmospheres when it was noted that blood was going back into the inflation device.The delivery system was removed from the guide catheter, but noted that the delivery balloon had disconnected from the shaft and remained inside the patient's body.The physician was able to deliver several emerge balloon catheters to crush the stent and balloon.A 3.50 x 16mm synergy xd stent was placed to jail the initial stent and balloon against the vessel wall.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
• MDR Report Key: 11004198
• Report Number: 2134265-2020-17535
• Device Sequence Number: 869467
• Product Code: NIQ
• UDI-Device Identifier: 08714729980957
• UDI-Public: 08714729980957
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2021

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: 07/02/2022
• Device Model Number: H7493941812300
• Device Lot Number: 0025685844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 12/06/2020; 01/20/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 12/21/2020; 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1