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

Model Number 9394

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ventricular Tachycardia (2132); Cardiogenic Shock (2262); Obstruction/Occlusion (2422)

Event Date 03/05/2020

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that during the procedure, patient deterioration occurred.Vascular access was obtained via the femoral artery.The 75% stenosed, long, eccentric, target lesion was located in the moderately tortuous right coronary (rca) artery.Predilatation was performed several times with a 2mm x 10mm semi compliant balloon.While the physician was positioning the 3.0 x 38mm promus element plus drug-eluting stent in the target lesion, the condition of the patient deteriorated and developed multiple problems.There was a disruption of flow to the distal rca associated with ischemic ventricular tachycardia and unstable hemodynamics.The patient was almost in a state of cardiogenic shock.To prioritize the patient stability, the physician removed the stent delivery system and other devices related to the procedure and abandoned the procedure.The patient was immediately taken to the intensive care unit where critical care was implemented.The patient was restless and in critical condition.The patient was treated with optimal medical therapy and when stabilized, was referred for coronary artery bypass graft.

Event Description

It was reported that during the procedure, patient deterioration occurred.Vascular access was obtained via the femoral artery.The 75% stenosed, long, eccentric, target lesion was located in the moderately tortuous right coronary (rca) artery.Predilitation was performed several times with a 2mm x 10mm semi compliant balloon.While the physician was positioning the 3.0 x 38mm promus element plus drug-eluting stent in the target lesion, the condition of the patient deteriorated and developed multiple problems.There was a disruption of flow to the distal rca associated with ischemic ventricular tachycardia and unstable hemodynamics.The patient was almost in a state of cardiogenic shock.To prioritize the patient stability, the physician removed the stent delivery system and other devices related to the procedure and abandoned the procedure.The patient was immediately taken to the intensive care unit where critical care was implemented.The patient was restless and in critical condition.The patient was treated with optimal medical therapy and when stabilized, was referred for coronary artery bypass graft.

Manufacturer Narrative

Device is a combination product.Device returned to manufacturer: a visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent outer diameter was measured within maximum crimped stent profile measurement per specifications.The balloon was 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 tactile examination of the hypotube found a kink located at 32.8cm distal to distal end of strain relief.A visual and tactile examination of the shaft polymer extrusion found no issues.Visual and microscopic examination found no issues with the tip.No other issues were identified during the product analysis.

• Brand Name: PROMUS ELEMENT PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9900589
• MDR Text Key: 187714716
• Report Number: 2134265-2020-04056
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2021
• Device Model Number: 9394
• Device Catalogue Number: 9394
• Device Lot Number: 0024518121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Date Manufacturer Received: 05/26/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR