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

Lot Number 0029487369

Device Problems Break (1069); Difficult to Remove (1528); Material Rupture (1546); Difficult to Advance (2920); Activation Failure (3270)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/14/2023

Event Type  Injury  

Event Description

It was reported that device issues occurred resulting in removal difficulties and additional interventions.The target lesion was located in the right coronary artery (rca).Atherectomy was performed with a 1.25mm rota burr without complication and the physician chose to continue intervention over the rotawire.Following pre-dilation using an emerge balloon, a 2.75x16 synergy xd was introduced, but it was unable to pass the proximal lesion and was deployed in the proximal rca lesion.Post deployment, the stent delivery system (sds) was removed outside the patient, but it was difficult to remove from the end of the rotawire.Significant force was applied and the stent hypotube broke with the hypotube remaining on the wire.The rotawire was left in place and an attempt was made to buddy wire using multiple luge guidewires.The luge wire kept getting stuck on or behind the stent strut, so the physician decided to cut the back of the rotawire and continue intervention over the part of the wire already across the lesion.A second 2.75 x16 synergy xd stent was advanced but it was unable to cross the lesion past the first deployed stent.The physician attempted to cross using a 2.75 x 18 non-boston scientific (non-bsc) stent, but it also would not cross.A guidezilla guide extension catheter was used to make another attempt at crossing using the 2.75 x 16 synergy xd stent.The stent was advanced with some difficulty and during deployment, the balloon ruptured.When the sds was removed, it was noted that the hypotube and balloon remained inside the patient and the physician was not sure that the stent had fully expanded distally.Multiple failed attempts were made to snare the broken balloon/hypotube.The physician attempted to rewire multiple wires, but the wires were unable to advance through the stent mid-section with the balloon still within the stent and with questionable distal expansion.A samurai wire was finally used to successfully wire the rca but it was behind the distal stent struts of the broken stent.The physician was reluctant to crush the balloon in place despite successful wire placement due to the length of the remaining piece in the aorta.The patient remained stable throughout.Another physician was consulted and joined the procedure.The lesion was again successfully wired with a samurai wire and additional snaring was attempted.The broken piece was snared but would not dislodge from the stent for removal.A balloon was inflated crushing the stent/balloon to prevent further movement or thrombosis.Additional non-bsc stents were deployed distally to treat the dissection that had occurred due to multiple wire attempts and the prolonged case time.The patient was admitted to the intensive care unit and will remain on anticoagulation indefinitely due to the unretrieved device fragment.

Event Description

It was reported that device issues occurred resulting in removal difficulties and additional interventions.The target lesion was located in the right coronary artery (rca).Atherectomy was performed with a 1.25mm rota burr without complication and the physician chose to continue intervention over the rotawire.Following pre-dilation using an emerge balloon, a 2.75x16 synergy xd was introduced, but it was unable to pass the proximal lesion and was deployed in the proximal rca lesion.Post deployment, the stent delivery system (sds) was removed outside the patient, but it was difficult to remove from the end of the rotawire.Significant force was applied and the stent hypotube broke with the hypotube remaining on the wire.The rotawire was left in place and an attempt was made to buddy wire using multiple luge guidewires.The luge wire kept getting stuck on or behind the stent strut, so the physician decided to cut the back of the rotawire and continue intervention over the part of the wire already across the lesion.A second 2.75 x16 synergy xd stent was advanced but it was unable to cross the lesion past the first deployed stent.The physician attempted to cross using a 2.75 x 18 non-boston scientific (non-bsc) stent, but it also would not cross.A guidezilla guide extension catheter was used to make another attempt at crossing using the 2.75 x 16 synergy xd stent.The stent was advanced with some difficulty and during deployment, the balloon ruptured.When the sds was removed, it was noted that the hpotube and balloon remained inside the patient and the physician was not sure that the stent had fully expanded distally.Multiple failed attempts were made to snare the broken balloon/hypotube.The physician attempted to rewire multiple wires, but the wires were unable to advance through the stent mid-section with the balloon still within the stent and with questionable distal expansion.A samurai wire was finally used to successfully wire the rca but it was behind the distal stent struts of the broken stent.The physician was reluctant to crush the balloon in place despite successful wire placement due to the length of the remaining piece in the aorta.The patient remained stable throughout.Another physician was consulted and joined the procedure.The lesion was again successfully wired with a samurai wire and additional snaring was attempted.The broken piece was snared but would not dislodge from the stent for removal.A balloon was inflated crushing the stent/balloon to prevent further movement or thrombosis.Additional non-bsc stents were deployed distally to treat the dissection that had occurred due to multiple wire attempts and the prolonged case time.The patient was admitted to the intensive care unit and will remain on anticoagulation indefinitely due to the unretrieved device fragment.

Manufacturer Narrative

Device evaluated by mfr.: a section of synergy xd mr us 2.75 x 16mm was returned for analysis.A visual, tactile and microscopic examination was performed.Multiple kinking was identified along the hypotube and a break was confirmed in the midshaft extrusion.The break was located at the location of guidewire exit port.The break site identified that the midshaft was stretched.The distal section of the break including the distal sections of the distal extrusion, balloon and tip section of the device was not returned for analysis.A microscopic examination of the kinks along hypotube, identified no issues with the hypotube which could have contributed to the kinks.

• 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: 17686130
• MDR Text Key: 322675481
• Report Number: 2124215-2023-46135
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729980889
• UDI-Public: 08714729980889
• 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
• Report Date: 10/04/2023

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 Expiration Date: 05/16/2024
• Device Lot Number: 0029487369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 09/30/2023
• Supplement Dates FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• 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): Hospitalization; Required Intervention