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

Model Number 10672

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/23/2022

Event Type  Death  

Event Description

It was reported that shaft break occurred and the patient died.Vascular access was obtained via femoral artery.The 98% stenosed, 50x25mm, eccentric and de novo target lesion with a bend of between 45 and 90 degrees was located in the severely tortuous and moderately calcified left anterior descending artery.After a 6f non-boston scientific (bsc) guide catheter and a 0.014 non-bsc guidewire crossed the lesion, pre-dilatation was performed with a 1.5 x 15 mm and 2.0x12mm balloon catheters leaving 98% residual stenosis.A 16 x 2.25 promus elite drug-eluting stent was advanced for treatment.However, during the procedure without any force or pressure, the stent's hypotube was cut.The procedure was completed; however, after the procedure, the patient died.

Event Description

It was reported that shaft break occurred and the patient died.Vascular access was obtained via femoral artery.The 98% stenosed, 50x25mm, eccentric and de novo target lesion with a bend of between 45 and 90 degrees was located in the severely tortuous and moderately calcified left anterior descending artery.After a 6f non-boston scientific (bsc) guide catheter and a 0.014 non-bsc guidewire crossed the lesion, pre-dilatation was performed with a 1.5 x 15 mm and 2.0x12mm balloon catheters leaving 98% residual stenosis.A 16 x 2.25 promus elite drug-eluting stent was advanced for treatment.However, during the procedure without any force or pressure, the stent's hypotube was cut.The procedure was completed; however, after the procedure, the patient died.It was further reported that there was no resistance encountered while removing the stent.The hypotube was cut outside the patient, so the device was removed from the remaining end with no material left inside the patient.

Manufacturer Narrative

D6a implant date: corrected.The promus elite ous mr 16 x 2.25mm stent delivery system was returned for analysis.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.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 damage.A visual and tactile examination of the hypotube shaft found a break situated at 20cm distal to the distal end of strain relief as well as multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

Event Description

It was reported that shaft break occurred and the patient died.Vascular access was obtained via femoral artery.The 98% stenosed, 50x25mm, eccentric and de novo target lesion with a bend of between 45 and 90 degrees was located in the severely tortuous and moderately calcified left anterior descending artery.After a 6f non-boston scientific (bsc) guide catheter and a 0.014 non-bsc guidewire crossed the lesion, pre-dilatation was performed with a 1.5 x 15 mm and 2.0x12mm balloon catheters leaving 98% residual stenosis.A 16 x 2.25 promus elite drug-eluting stent was advanced for treatment.However, during the procedure without any force or pressure, the stent's hypotube was cut.The procedure was completed; however, after the procedure, the patient died.It was further reported that there was no resistance encountered while removing the stent.The hypotube was cut outside the patient, so the device was removed from the remaining end with no material left inside the patient.

• 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: 13971947
• MDR Text Key: 288349660
• Report Number: 2134265-2022-03752
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AR
• 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: 09/08/2022

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: 02/02/2023
• Device Model Number: 10672
• Device Catalogue Number: 10672
• Device Lot Number: 0026797713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 04/27/2022; 09/07/2022
• Supplement Dates FDA Received: 04/29/2022; 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2021
• 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
• Treatment: GUIDE CATHETER - 6F 3.5 EBU; GUIDE CATHETER - 6F 3.5 EBU; GUIDE CATHETER - 6F 3.5 EBU
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 70 KG