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

Model Number 10674

Device Problems Entrapment of Device (1212); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2024

Event Type  Injury  

Event Description

It was reported that catheter entrapment occurred.A 24 x 2.75 promus elite drug eluting stent was advanced for treatment.However, when treating a bifurcation, the second stent failed to advance, resulting in entrapment.Both stents were removed, and new stents were used to complete the procedure.The patient left the hemodynamics room in stable condition.

Event Description

It was reported that catheter entrapment occurred.A 24 x 2.75 promus elite drug eluting stent was advanced for treatment.However, when treating a bifurcation, the second stent failed to advance, resulting in entrapment.Both stents were removed, and new stents were used to complete the procedure.The patient left the hemodynamics room in stable condition.It was further reported that an angioplasty of the anterior descending artery bifurcation was performed on the proximal third and diagonal branch.The stenosed lesion was 80% in the anterior descending artery and 70% in the non-calcified diagonal branch.A boston scientific convey leftbu 3.5 guide catheter and a non-boston scientific 6 fr were used.Pre-dilatation involved 2.0 x 8 and 2.0 x 12 emerge balloon catheters.However, difficulties arose when positioning both stents as they became stuck together, rendering them immovable.Initially, the stent was placed in the diagonal branch.Attempts to position the lad stent were unsuccessful due to them sticking together.Eventually, everything was removed, wires, stents, and catheter had to be removed and the procedure had to be restarted from the beginning.The stents were noted to be "hooked together" but not trapped inside the artery.Dissection occurred upon the removal of all of the devices.Stents were placed in the diagonal branch, and several stents were implanted in the anterior descending artery to cover the dissection and to complete the procedure.

Event Description

It was reported that catheter entrapment occurred.A 24 x 2.75 promus elite drug eluting stent was advanced for treatment.However, when treating a bifurcation, the second stent failed to advance, resulting in entrapment.Both stents were removed, and new stents were used to complete the procedure.The patient left the hemodynamics room in stable condition.It was further reported that an angioplasty of the anterior descending artery bifurcation was performed on the proximal third and diagonal branch.The stenosed lesion was 80% in the anterior descending artery and 70% in the non-calcified diagonal branch.A boston scientific convey leftbu 3.5 guide catheter and a non-boston scientific 6 fr were used.Pre-dilatation involved 2.0 x 8 and 2.0 x 12 emerge balloon catheters.However, difficulties arose when positioning both stents as they became stuck together, rendering them immovable.Initially, the stent was placed in the diagonal branch.Attempts to position the lad stent were unsuccessful due to them sticking together.Eventually, everything was removed, wires, stents, and catheter had to be removed and the procedure had to be restarted from the beginning.The stents were noted to be "hooked together" but not trapped inside the artery.Dissection occurred upon the removal of all of the devices.Stents were placed in the diagonal branch, and several stents were implanted in the anterior descending artery to cover the dissection and to complete the procedure.It was further reported that the backward traction of the chordae may have caused a dissection in a segment previously treated with a balloon.The prosthesis, or stents, were adhered together, preventing any movement forward or backward, and were not positioned where they were supposed to be implanted, necessitating their removal.The dissection was a result of the coronary cord removal, and the complications were worsened by the stents becoming entangled.The dissection restricted flow, requiring a long segment to be stented to reestablish flow.

Manufacturer Narrative

Updated b5 - describe event or problem: updated to include new information obtained.Device evaluated by manufacturer: a visual, tactile and microscopic examination was performed.An examination of the returned device identified that the mid-shaft was severely stretched.A microscopic examination of the distal extrusion noted that the inner/wire lumen was bunched at 6.3 from the bumper tip of the device.It was not possible to a load a recommended 0.014inch size wire through the wire lumen due to the inner/wire lumen damage.A visual and tactile examination identified that the hypotube was kinked at various locations along its length.An examination of the crimped stent identified no damages.No other issues were noted with the device.

• Brand Name: PROMUS ELITE
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• 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: 19031762
• MDR Text Key: 339233460
• Report Number: 2124215-2024-20183
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2024

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: 10674
• Device Catalogue Number: 10674
• Device Lot Number: 0029653063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/03/2024; 04/29/2024
• Supplement Dates FDA Received: 04/26/2024; 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2022
• 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: CONVEY LEFTBU 3.5; GUIDE CATHETER: CONVEY LEFTBU 3.5; GUIDEWIRE: 6 FR; GUIDEWIRE: 6 FR
• Patient Outcome(s): Required Intervention
• Patient Sex: Male