MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-13 for GRAFTMASTER 1012581-26 manufactured by Abbott Vascular.
[183274790]
(b)(4). The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no similar incidents from this lot. The graftmaster was used past the expiration date. A review of the graftmaster label attached to the lot history record for this lot was conducted indicating a manufacturing date of (b)(6) 2018 with an expiration date (use by date) of (b)(6) 2019. The product was used after expiration as it was reported the procedure occurred on (b)(6) 2020. The expiration date of the product is important for sterility, efficacy, and performance of the device. It should be noted that the graftmaster rapid exchange (rx), coronary stent graft system, domestic instructions for use, states: note the product use by date specified on the package. The investigation determined the reported device expiration issue appears to be related to the use error. There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Patient Sequence No: 1, Text Type: N, H10
[183274791]
It was reported that a 3. 5x26mm graftmaster covered stent was used to treat a free perforation that occurred in the mid left anterior descending coronary artery on (b)(6) 2020. The stent successfully covered the perforation; however, the stent was used after the expiration date of (b)(6) 2019. As per the physician, the graftmaster did not cause or contribute to additional complications or adverse events. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02397 |
| MDR Report Key | 9828965 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2018-01-17 |
| Date Added to Maude | 2020-03-13 |
| 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 | GRAFTMASTER |
| Generic Name | CORONARY STENT DELIVERY SYSTEM |
| Product Code | MAF |
| Date Received | 2020-03-13 |
| Model Number | 1012581-26 |
| Catalog Number | 1012581-26 |
| Lot Number | 8011741 |
| Device Expiration Date | 2019-12-31 |
| 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 | 2020-03-13 |