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 RX PRIME 1011709-18 manufactured by Abbott Vascular.
[187715268]
The device was not returned for evaluation. The reported patient effect of intimal dissection is listed in the xience prime everolimus eluting coronary stent system (eecss), instructions for use as a known patient effect of coronary stenting procedures. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Based on the information reviewed, there is no indication of a product quality issue. A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Patient Sequence No: 1, Text Type: N, H10
[187715269]
It was reported that the procedure was performed to treat a mildly tortuous, 99% stenosed, de novo lesion in the left anterior descending artery. A 3. 0. X18mm xience prime stent was deployed at 10 atmospheres (atms). Post-dilatation was performed with a 3. 0x12mm unspecified nc balloon dilatation catheter at 14 atms; however, a distal edge dissection was noted. A 3. 0x15mm xience prime stent was implanted to successfully treat the dissection. There were no adverse patient sequela and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03105 |
| MDR Report Key | 9899750 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2019-06-24 |
| 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 | MS. LINDSEY BELL |
| Manufacturer Street | 26531 YNEZ RD. |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, REG # 3005718570 (P099) |
| Manufacturer Street | CASHEL ROAD |
| Manufacturer City | CLONMEL TIPPERARY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RX PRIME |
| Generic Name | DRUG ELUTING CORONARY STENT DELIVERY SYSTEM |
| Product Code | NIQ |
| Date Received | 2020-03-30 |
| Catalog Number | 1011709-18 |
| Lot Number | 9061841 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Manufacturer Address | 26531 YNEZ RD. TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |