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

Model Number 9553

Device Problems Entrapment of Device (1212); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that device entrapment occurred.The patient presented with late st-elevation myocardial infarction (stemi).Emergency coronary angiography showed 99% stenosed, sub-occluded lesion in the middle segment and occlusion in the distal segment of the circumflex artery.Following pre-dilatation, a 32 x 2.25 promus premier drug-eluting stent was advanced for treatment.However, during introduction, the stent got stuck with the guidewire.The entire system was removed and it was noted that the delivery system was totally damaged.The procedure was completed with another of same device.No patient complications were reported.

Event Description

It was reported that device entrapment occurred.The patient presented with late st-elevation myocardial infarction (stemi).Emergency coronary angiography showed 99% stenosed, sub-occluded lesion in the middle segment and occlusion in the distal segment of the circumflex artery.Following pre-dilatation, a 32 x 2.25 promus premier drug-eluting stent was advanced for treatment.However, during introduction, the stent got stuck with the guidewire.The entire system was removed and it was noted that the delivery system was totally damaged.The procedure was completed with another of same device.No patient complications were reported.

Manufacturer Narrative

E1.Initial reporter facility name: hospital.The promus premier ous mr 32 x 2.25 stent delivery system (sds) was returned for analysis.An examination of the crimped stent found that the stent was damaged on almost its entire length.Stent struts from proximal to mid stent were lifted and bunched in the mid stent region.Stent struts from the distal region were lifted and pulled distally.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture was within max 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 tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the inner, outer and mid-shaft sections found the inner and outer shaft to be flattened/damaged and kinked.A break in the shaft extrusion was also noted at the exchange port.No other issues were identified during the product analysis.

• Brand Name: PROMUS PREMIER
• 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: 13664843
• MDR Text Key: 286573351
• Report Number: 2134265-2022-02228
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2023
• Device Model Number: 9553
• Device Catalogue Number: 9553
• Device Lot Number: 0027382470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/03/2022
• Supplement Dates Manufacturer Received: 09/28/2022
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2021
• 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
• Patient Sex: Male