MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-30 for PROMUS ELEMENT PLUS 9394 manufactured by Boston Scientific Corporation.
[187714716]
Device is a combination product.
Patient Sequence No: 1, Text Type: N, H10
[187714717]
It was reported that during the procedure, patient deterioration occurred. Vascular access was obtained via the femoral artery. The 75% stenosed, long, eccentric, target lesion was located in the moderately tortuous right coronary (rca) artery. Predilatation was performed several times with a 2mm x 10mm semi compliant balloon. While the physician was positioning the 3. 0 x 38mm promus element plus drug-eluting stent in the target lesion, the condition of the patient deteriorated and developed multiple problems. There was a disruption of flow to the distal rca associated with ischemic ventricular tachycardia and unstable hemodynamics. The patient was almost in a state of cardiogenic shock. To prioritize the patient stability, the physician removed the stent delivery system and other devices related to the procedure and abandoned the procedure. The patient was immediately taken to the intensive care unit where critical care was implemented. The patient was restless and in critical condition. The patient was treated with optimal medical therapy and when stabilized, was referred for coronary artery bypass graft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-04056 |
| MDR Report Key | 9900589 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-14 |
| Device Manufacturer Date | 2019-09-24 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROMUS ELEMENT PLUS |
| Generic Name | STENT, CORONARY, DRUG-ELUTING |
| Product Code | NIQ |
| Date Received | 2020-03-30 |
| Model Number | 9394 |
| Catalog Number | 9394 |
| Lot Number | 0024518121 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |