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

Model Number 10619

Device Problem Break (1069)

Patient Problems Hematoma (1884); Vascular Dissection (3160)

Event Date 07/14/2023

Event Type  Injury  

Event Description

It was reported a shaft break occurred, followed by a dissection and hematoma, requiring additional intervention.A nc quantum apex balloon and a synergy ii des stent balloon were selected for use in a percutaneous coronary intervention (pci) procedure.The balloon fractured and had to be retrieved.The intact, fractured balloon was trapped inside the guide catheter using the guidewire and the entire system was removed.Ivus showed a dissection and hematoma.The cause for the reported dissection and hematoma remains unknown.Additional stenting was performed to resolve the injuries.The patient was fully recovered.

Event Description

It was reported a shaft break occurred, followed by a dissection and hematoma, requiring additional intervention.A nc quantum apex balloon and a synergy ii des stent balloon were selected for use in a percutaneous coronary intervention (pci) procedure.The balloon fractured and had to be retrieved.The intact, fractured balloon was trapped inside the guide catheter using the guidewire and the entire system was removed.Ivus showed a dissection and hematoma.The cause for the reported dissection and hematoma remains unknown.Additional stenting was performed to resolve the injuries.The patient was fully recovered.Additional information: it was further reported that the severely calcified, moderately tortuous, 80% stenosed bifurcation lesion was located in the ostial diagonal and evolved to the left anterior descending artery (lad).Additionally, there was a previously implanted under-expanded stent.The patient was presenting with chest pain, believed to be caused by the under-expanded stents.Intravascular ultrasound(ivus) confirmed a gap at the ostial diagonal, and this was the target region to stent.However, the stent could not be delivered.The lad stent was ballooned further, but could still not be delivered.The kissing technique was attempted using two 3.0mm x 12mm nc quantum devices.The first nc quantum apex was placed in the diagonal ostium, and when trying to place the second nc quantum apex in the lad, the device jammed at the tip of the guide catheter and could not be moved forward or backward.The balloons were pulled out together, and the first nc quantum balloon fractured.The second nc quantum balloon was removed intact.The stiff section of the fractured balloon was removed, however, the soft remaining section of the nc quantum device system moved back (during pulling) from the ostial diagonal to just beyond the tip of the guide catheter and remained on the diagonal wire.The fractured nc quantum section was retrieved by another semi-complaint balloon 2.0 x 8 which was inflated on the lad wire at low pressure beyond the detached portion.The noted dissection occurred in the proximal lad prior to the existing stent, which was diseased and planned to be stented.The cause of the dissection is unknown, but according to the physician predilation by the 3.0 x 12 nc quantum or the act of pulling the inflated balloon for the retrieval of the fractured device could have expanded the existing dissection.The dissection was covered by a stent.It was additionally noted that the synergy stent fractured outside the guide catheter and outside of the body.However, the timeline of when this fracture occurred in regards to the procedure is not known.

Manufacturer Narrative

Device evaluated by manufacturer: a synergy ous mr 3.00 x 20mm stent delivery system (sds) was returned for analysis.A hypotube kink was noted 22.5cm distal to the distal end of the strain relief and a break at 25.8cm distal to the distal end of the strain relief.At the laser cut region the shaft was damaged, 35.8cm proximal from the tip of the device.No other device issues were identified during returned product analysis.

• Brand Name: SYNERGY
• 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: 17476141
• MDR Text Key: 320564686
• Report Number: 2124215-2023-41935
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

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 Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0030801085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2023
• 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): Required Intervention