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

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.

• 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 Key: 17393725
• MDR Text Key: 319737181
• Report Number: 2124215-2023-35245
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981046
• UDI-Public: 08714729981046
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Number: 0030756402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 07/24/2023; 10/06/2023
• Supplement Dates FDA Received: 08/18/2023; 10/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 124 KG
• Patient Race: White