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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT Back to Search Results
Lot Number 0030756402
Device Problem Break (1069)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Vascular Dissection (3160)
Event Date 06/23/2023
Event Type  Death  
Event Description
It was reported that shaft break and dissection occurred, and the patient died.The 90% stenosed target lesion was located in the moderately calcified proximal left anterior descending (lad) artery.A 3.50 x 16mm synergy xd drug-eluting stent was advanced for treatment after receiving non-boston scientific balloon lithotripsy therapy.During the procedure, two non-boston scientific indeflator devices locked up while attempting to inflate the stent.Eventually, the second inflation device was able to inflate the synergy stent balloon to nominal pressure and deployed the stent.During removal of the catheter after stent placement, the mid shaft was found to be fractured.The physician carefully removed the wire and the guide catheter since he noticed that the distal part of the catheter was still attached to the wire on the monorail segment.The device was successfully removed from the patient.There were no patient complications found when the catheter was removed, but the patient started to develop bradycardia after the final angiogram was performed.It was noted that the patient felt excruciating pain when the lithotripsy balloon crossed the lesion and the pain level increased as they started delivering therapy.The patient died after coding for a few minutes.It was confirmed that a coronary artery dissection was the cause of death.
 
Event Description
It was reported that shaft break and dissection occurred, and the patient died.The 90% stenosed target lesion was located in the moderately calcified proximal left anterior descending (lad) artery.A 3.50 x 16mm synergy xd drug-eluting stent was advanced for treatment after receiving non-boston scientific balloon lithotripsy therapy.During the procedure, two non-boston scientific indeflator devices locked up while attempting to inflate the stent.Eventually, the second inflation device was able to inflate the synergy stent balloon to nominal pressure and deployed the stent.During removal of the catheter after stent placement, the mid shaft was found to be fractured.The physician carefully removed the wire and the guide catheter since he noticed that the distal part of the catheter was still attached to the wire on the monorail segment.The device was successfully removed from the patient.There were no patient complications found when the catheter was removed, but the patient started to develop bradycardia after the final angiogram was performed.It was noted that the patient felt excruciating pain when the lithotripsy balloon crossed the lesion and the pain level increased as they started delivering therapy.The patient died after coding for a few minutes.It was confirmed that a coronary artery dissection was the cause of death.It was further reported that the dissection was located in the left main stem and the cause of the dissection is unknown.There were five stents implanted in the patient.It was noted that one of the stents sheared off the stent balloon and was stented against the vessel wall but specific product detail was not provided.The percutaneous stents were successfully placed and there was an excellent stent apposition.At the end of the procedure, the patient had timi-3 flow and no in-stent restenosis.The case was finished, and the catheters were removed.The patients blood pressure then dropped, a code blue was called, and an attempt was made to resuscitate the patient for 30 minutes.The patient briefly regained spontaneous circulation but then lost it again and, despite efforts, they were unable to get the patient back.It was noted that the defective device did not cause the patients demise.
 
Event Description
It was reported that shaft break and dissection occurred, and the patient died.The 90% stenosed target lesion was located in the moderately calcified proximal left anterior descending (lad) artery.A 3.50 x 16mm synergy xd drug-eluting stent was advanced for treatment after receiving non-boston scientific balloon lithotripsy therapy.During the procedure, two non-boston scientific indeflator devices locked up while attempting to inflate the stent.Eventually, the second inflation device was able to inflate the synergy stent balloon to nominal pressure and deployed the stent.During removal of the catheter after stent placement, the mid shaft was found to be fractured.The physician carefully removed the wire and the guide catheter since he noticed that the distal part of the catheter was still attached to the wire on the monorail segment.The device was successfully removed from the patient.There were no patient complications found when the catheter was removed, but the patient started to develop bradycardia after the final angiogram was performed.It was noted that the patient felt excruciating pain when the lithotripsy balloon crossed the lesion and the pain level increased as they started delivering therapy.The patient died after coding for a few minutes.It was confirmed that a coronary artery dissection was the cause of death.It was further reported that the dissection was located in the left main stem and the cause of the dissection is unknown.There were five stents implanted in the patient.It was noted that one of the stents sheared off the stent balloon and was stented against the vessel wall but specific product detail was not provided.The percutaneous stents were successfully placed and there was an excellent stent apposition.At the end of the procedure, the patient had timi-3 flow and no in-stent restenosis.The case was finished, and the catheters were removed.The patients blood pressure then dropped, a code blue was called, and an attempt was made to resuscitate the patient for 30 minutes.The patient briefly regained spontaneous circulation but then lost it again and, despite efforts, they were unable to get the patient back.It was noted that the defective device did not cause the patients demise.Device evaluated by mfr: the device was not returned for analysis.However, a photo was attached to the complaint record 16843432 identifying a synergy xd 3.50 x 16mm device that was split into two and placed into clear biohazard bags.There were multiple kinks on the hypotube shaft and a break near the mid shaft of the device with the core wire exposed.The balloon appeared to be inflated with blood residue, and the distal part of the device, from the port exchange to the tip, was detached.The stent was deployed inside the patient.
 
Manufacturer Narrative
Device evaluated by mfr: the device was not returned for analysis.However, a photo was attached to the complaint record identifying a synergy xd 3.50 x 16mm device that was split into two and placed into clear biohazard bags.There were multiple kinks on the hypotube shaft and a break near the mid shaft of the device with the core wire exposed.The balloon appeared to be inflated with blood residue, and the distal part of the device, from the port exchange to the tip, was detached.The stent was deployed inside the patient.
 
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Brand Name
SYNERGY XD
Type of Device
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 Key17393725
MDR Text Key319737181
Report Number2124215-2023-35245
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729981046
UDI-Public08714729981046
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 10/27/2023
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
Device Operator Health Professional
Device Lot Number0030756402
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/25/2023
Supplement Dates Manufacturer Received07/24/2023
10/06/2023
Supplement Dates FDA Received08/18/2023
10/29/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/14/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age66 YR
Patient SexMale
Patient Weight124 KG
Patient RaceWhite
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