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

Model Number 9388

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent dislodgement occurred.The patient presented with vessel occlusion.A 3.50x24mm promus element plus drug-eluting stent was advanced for treatment.However, during the procedure, the stent was dislodged.The procedure was not completed due to this event.No patient complications were reported and the patient status was stable.

Event Description

It was reported that stent dislodgement occurred.The patient presented with vessel occlusion.A 3.50x24mm promus element plus drug-eluting stent was advanced for treatment.However, during the procedure, the stent was dislodged.The procedure was not completed due to this event.No patient complications were reported and the patient status was stable.It was further reported that vascular access was obtained via radial artery and the target lesion was 80% stenosed and 80% calcified.The final location of the dislodged stent was on the left anterior descending artery.The device was not completely removed from the patient's body and the procedure was completed by implanting the second stent at the lesion.

Manufacturer Narrative

A promus element plus,mr,ous 3.50x24mm stent delivery system was returned for analysis without the stent.An examination of the crimped stent found that the stent was not returned with the device.A review of the manufacturing stent profile data was performed and the stent od (outer diameter) at the time of manufacture was within maximum crimped stent profile measurement.The balloon cones were reviewed, and signs of positive pressure applied to the cones were noted as its wings were relaxed and not tightly folded.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 no issues.A visual and tactile examination of the outer and mid-shaft section found a kink in the midshaft section with the core wire also bent and measured at 260mm proximal to distal end of tip.Bunching of the inner shaft polymer extrusion was noted measured at 66mm proximal to distal end of tip.Additionally, the guidewire exchange port was noted to present a tear 4mm in length distal to the exchange port.No other issues were identified during the product analysis.A cd containing a series of angiographic images was returned with the complaint device and reviewed.A guide catheter was in position at the lm(left main) ostium and contrast flow assessment of the left main arteries showed views of the left main coronary arteries.No treatment of any lesions were noted in lm arteries and no attempts to deploy a stent or a dislodgement of any stent was noted.The remaining series showed treatment of rca(right coronary artery) with views under flow contrast noting the distal end of the guide catheter positioned at the ostium of rca and a lesion site identified as a constricted region in the proximal rca.A guidewire was seen placed trough rca without any pre dilations being noted.A stent was seen placed and deployed at the lesion site followed by assessment which showed no significant improvement in the flow at the lesion site.Another stent was seen being positioned at the proximal end of the first one and deployed, however, no further images were available to asses if this second deployment was successful in opening the narrowing present in proximal rca.A review of the media provided could not identify the alleged stent dislodgement as the only 2 stents visible in the images provided were deployed at a lesion site in proximal rca without any issues.The event description mentions that the alleged dislodgement took place in lad(left anterior descending), however, no treatment of lad could be noted in the images reviewed.

Manufacturer Narrative

Corrected h6 patient codes.Updated b5: describe event or problem.

Event Description

It was reported that stent dislodgement occurred.The patient presented with vessel occlusion.A 3.50x24mm promus element plus drug-eluting stent was advanced for treatment.However, during the procedure, the stent was dislodged.The procedure was not completed due to this event.No patient complications were reported and the patient status was stable.It was further reported that vascular access was obtained via radial artery and the target lesion was 80% stenosed and 80% calcified.The final location of the dislodged stent was on the left anterior descending artery.The device was not completely removed from the patient's body and the procedure was completed by implanting the second stent at the lesion.

• 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: 10265017
• MDR Text Key: 198555870
• Report Number: 2134265-2020-09066
• 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,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2021
• Device Model Number: 9388
• Device Catalogue Number: 9388
• Device Lot Number: 0023457323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 65