MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; STENT, CORONARY, DRUG-ELUTING

Model Number 10677

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problems Dyspnea (1816); Rash (2033); Shock (2072); Tachycardia (2095); Bronchospasm (2598); Swelling/ Edema (4577)

Event Date 05/13/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced an allergic reaction, and the procedure was cancelled.Vascular access was obtained via the right radial artery.The 90% stenosed, 2.5mmx38mm, concentric, de novo target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery (lad).The patient presented during percutaneous transluminal coronary angioplasty (ptca) of the lad with anaphylactic shock, hypertension, tachycardia, dyspnea and obstructed 2.5mm x 38mm promus elite drug-eluting stent.It was noted that there was resistance felt during insertion/advancement to the target lesion, however, it was reported that the stent was damaged during resuscitation.It was also noted that the patient experienced hives, angioedema, bronchospasm and rash.Medication was administered and the event was resolved, however, the procedure was not completed due to this event.The patient was stable following the procedure.

Event Description

It was reported that the patient experienced an allergic reaction, and the procedure was cancelled.Vascular access was obtained via the right radial artery.The 90% stenosed, 2.5mmx38mm, concentric, de novo target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery (lad).The patient presented during percutaneous transluminal coronary angioplasty (ptca) of the lad with anaphylactic shock, hypertension, tachycardia, dyspnea and obstructed 2.5mm x 38mm promus elite drug-eluting stent.It was noted that there was resistance felt during insertion/advancement to the target lesion, however, it was reported that the stent was damaged during resuscitation.It was also noted that the patient experienced hives, angioedema, bronchospasm and rash.Medication was administered and the event was resolved, however, the procedure was not completed due to this event.The patient was stable following the procedure.It was further reported that during this procedure, there was no other stent deployed on the patient and the stent that was used was not inflated.The patient experienced no allergic reaction on previous implanted stents.

Manufacturer Narrative

(h6) evaluation conclusion codes updated from known inherent risk of device to adverse event related to patient condition.Device evaluated by mfr.: promus elite ous mr 38 x 2.50mm stent delivery system was returned for analysis.Examination of the crimped stent via scope found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks along several locations of the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.The device could be loaded on a 0.014" test guidewire without issues.No other issues were identified during the product analysis.

Event Description

It was reported that the patient experienced an allergic reaction, and the procedure was cancelled.Vascular access was obtained via the right radial artery.The 90% stenosed, 2.5mmx38mm, concentric, de novo target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery (lad).The patient presented during percutaneous transluminal coronary angioplasty (ptca) of the lad with anaphylactic shock, hypertension, tachycardia, dyspnea and obstructed 2.5mm x 38mm promus elite drug-eluting stent.It was noted that there was resistance felt during insertion/advancement to the target lesion, however, it was reported that the stent was damaged during resuscitation.It was also noted that the patient experienced hives, angioedema, bronchospasm and rash.Medication was administered and the event was resolved, however, the procedure was not completed due to this event.The patient was stable following the procedure.It was further reported that during this procedure, there was no other stent deployed on the patient and the stent that was used was not inflated.The patient experienced no allergic reaction on previous implanted stents.

• Brand Name: PROMUS ELITE
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14688647
• MDR Text Key: 294021497
• Report Number: 2134265-2022-06365
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: LE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2023
• Device Model Number: 10677
• Device Catalogue Number: 10677
• Device Lot Number: 0027966799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2021
• 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; Hospitalization; Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 70 KG