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

Model Number 9394

Device Problems Break (1069); Positioning Failure (1158); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Bradycardia (1751); Ischemia (1942); Perforation (2001); Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 07/26/2021

Event Type  Death  

Event Description

It was reported that catheter removal difficulty and patient death occurred.Vascular access was via the right femoral artery.The 80% stenosed, 3.00 x 36mm, concentric target lesion was located in the non-tortuous and mildly calcified ostial left anterior descending artery.Following multiple dilatations at different pressures with 2.5 x 10mm and 2.75 x 15mm semi compliant balloons, the artery developed slow flow which was successfully managed with medications.An attempt was made to deploy a 3.00 x 38mm promus element plus drug eluting stent but the stent delivery system (sds) balloon could only be partially inflated.Different pressures and different inflation devices were used but the stent failed to be deployed at the desired pressure.While attempting to remove the device, the operator failed to deflate the balloon and had to forcefully pull out the device in a partially inflated state.This was only possible by removing the device, along with the guide catheter by cutting open the arterial sheath.In the process, the proximal part of the sds was torn and lost.Immediately after the incident, the patient developed bradycardia and slow flow.The slow flow was followed by no flow and an abrupt drop in blood pressure.Finally the patient went into asystole.To save the life of the patient, a 3.00 x 38mm non-boston scientific stent was successfully deployed in the target lesion through a new sheath and guide catheter.Eventually, however, the patient collapsed and died on the operating table.It was further reported that no other devices were used to help deliver the stent.No difficulty occurred while advancing the device.No significant bend was observed at the location of the lesion.No other device was present in the vessel.A boston scientific encore 26 inflation device was used to inflate the stent balloon device.Multiple inflations (3 to 4) times were attempted for 30 to 35 seconds.It was noted that every inflation attempt was at 16 atmospheres of pressure, with only the last inflation being at 18 atmospheres.During every inflation, the stent balloon was partially inflated from the first inflation itself.It was noted that the inflation device could not hold the pressure, and the inflation device was changed out twice.The contrast medium reached the balloon.Contrast medium was reported to be leaking at the proximal part of the balloon of the stent delivery system, on every attempt of inflation.It was clarified that the stent balloon was not deployed.The device was difficult to remove due to the partially inflated stent delivery system.(the balloon would not deflate after it was partially inflated).It was noted that as the balloon failed to inflate completely, the stent also failed to be deployed.There was stiff resistance while removing the partially inflated balloon through the guide catheter.The device was distinctly observed under fluoroscopy to confirm that no contraction occurred in the balloon.A boston scientific mach 1jl 3.5 6f guide catheter was noted to have been used during the procedure.It was noted that the device could not be removed through the guide catheter due to the stent delivery system (balloon and stent assembly) being partially inflated.The entire system (stent balloon assembly, guide catheter, guidewire, and arterial sheath) were removed together.

Manufacturer Narrative

H6: patient codes and h6: device codes: corrected.A 3.00 x 38mm promus element plus stent delivery system (sds) was returned for analysis without the hypotube shaft and manifold.Stent damage was noted with struts from the proximal to mid stent region lifted and pulled distally and struts from the distal stent region lifted and pulled distally.The undamaged crimp stent od was measured, and the result was within max crimped stent profile measurement.The balloon cones were reviewed and no signs of positive pressure were noted as its wings were folded.Crimp markings were visible on the exposed balloon wall and blood like substance was noted inside the balloon body.A visual and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found that the hypotube and manifold were not returned with the device.A visual and tactile examination of the outer and mid shaft section and a visual examination of the inner lumen found multiple kinks.Inner shaft polymer extrusion stretches were also identified at multiple locations.There was a break in the midshaft section of the device and measurements could not be taken due to stretching.The wire port was stretched and torn.The device could not be loaded successfully onto 0.0140 inch test guidewire due to extent of inner damage.Pressure was applied and the balloon did not inflate as it could not hold pressure due to a leak noted on the outer shaft polymer extrusion 5mm from the proximal balloon bond.A flushing needle attached to the encore inflation device was inserted into inflation lumen at the site of the outer shaft tear and clamped in place.An attempt made to inflate balloon by apply rated burst pressure per the instructions for use.The balloon inflated only partially as pressure could not be maintained in the inflation device due to further leaking at the flushing needle region.No other issues were identified during the product analysis.Media provided by the site was reviewed by boston scientific medical personnel.The angiographic media provided was consistent with the catheter removal difficulty (balloon failure to deflate) complaint.The images also demonstrated a coronary perforation occurring during pre dilation and temporary loss of target vessel guidewire access.Extraluminal (subintimal) placement of the guidewire likely occurred during rewiring through the site of vessel injury (perforation).The subintimal placement likely contributed to difficulty positioning the sds and may have damaged (kinked) the sds.Sds damage likely contributed to the no deflate event.The no deflate was managed by forceful withdrawal of the sds while still inflated and removal with the guide catheter as a unit.The extraluminally deployed stent sealed the distal lad from antegrade flow which caused vessel occlusion.Placement of an additional 38 mm stent as described in the event report was not evident during review of the complaint media.The resultant cardiac ischemia from the vessel occlusion caused by stenting in a dissection plane led to fatal pump failure.

Event Description

It was reported that catheter removal difficulty and patient death occurred.Vascular access was via the right femoral artery.The 80% stenosed, 3.00 x 36mm, concentric target lesion was located in the non-tortuous and mildly calcified ostial left anterior descending artery.Following multiple dilatations at different pressures with 2.5 x 10mm and 2.75 x 15mm semi compliant balloons, the artery developed slow flow which was successfully managed with medications.An attempt was made to deploy a 3.00 x 38mm promus element plus drug eluting stent but the stent delivery system (sds) balloon could only be partially inflated.Different pressures and different inflation devices were used but the stent failed to be deployed at the desired pressure.While attempting to remove the device, the operator failed to deflate the balloon and had to forcefully pull out the device in a partially inflated state.This was only possible by removing the device, along with the guide catheter by cutting open the arterial sheath.In the process, the proximal part of the sds was torn and lost.Immediately after the incident, the patient developed bradycardia and slow flow.The slow flow was followed by no flow and an abrupt drop in blood pressure.Finally the patient went into asystole.To save the life of the patient, a 3.00 x 38mm non-boston scientific stent was successfully deployed in the target lesion through a new sheath and guide catheter.Eventually, however, the patient collapsed and died on the operating table.It was further reported that no other devices were used to help deliver the stent.No difficulty occurred while advancing the device.No significant bend was observed at the location of the lesion.No other device was present in the vessel.A boston scientific encore 26 inflation device was used to inflate the stent balloon device.Multiple inflations (3 to 4) times were attempted for 30 to 35 seconds.It was noted that every inflation attempt was at 16 atmospheres of pressure, with only the last inflation being at 18 atmospheres.During every inflation, the stent balloon was partially inflated from the first inflation itself.It was noted that the inflation device could not hold the pressure, and the inflation device was changed out twice.The contrast medium reached the balloon.Contrast medium was reported to be leaking at the proximal part of the balloon of the stent delivery system, on every attempt of inflation.It was clarified that the stent balloon was not deployed.The device was difficult to remove due to the partially inflated stent delivery system.(the balloon would not deflate after it was partially inflated).It was noted that as the balloon failed to inflate completely, the stent also failed to be deployed.There was stiff resistance while removing the partially inflated balloon through the guide catheter.The device was distinctly observed under fluoroscopy to confirm that no contraction occurred in the balloon.A boston scientific mach 1jl 3.5 6f guide catheter was noted to have been used during the procedure.It was noted that the device could not be removed through the guide catheter due to the stent delivery system (balloon and stent assembly) being partially inflated.The entire system (stent balloon assembly, guide catheter, guidewire, and arterial sheath) were removed together.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12402860
• MDR Text Key: 269223109
• Report Number: 2134265-2021-11056
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• 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
• Report Date: 11/08/2021

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: 02/13/2022
• Device Model Number: 9394
• Device Catalogue Number: 9394
• Device Lot Number: 0025225698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 10/28/2021
• Supplement Dates FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2020
• 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): Death
• Patient Age: 56 YR
• Patient Sex: Male