MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-27 for ABSORB 1234350-23 manufactured by Abbott Vascular.
[183486484]
There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy. A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided. The reported patient effects of thrombosis and myocardial infarction, as listed in the absorb gt1 instructions for use, are known patient effects that may be associated with the use of a coronary scaffold in native coronary arteries. Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to design, manufacture or labeling of the device. The other additional absorb gt1 referenced is being filed under a separate medwatch report number.
Patient Sequence No: 1, Text Type: N, H10
[183486485]
It was reported that on (b)(6) 2015 the procedure was performed to treat the left anterior descending artery and two absorb gt1 scaffolds (3. 5x23mm and 2. 5x28mm) were implanted. One week after therapy was stopped, an acute posterior infarction occurred and scaffold-thrombosis was observed in the overlapping region of the two absorb scaffolds on (b)(6) 2016, the thrombosis was recanalized and dilatated with an unspecified balloon. Medication was provided as treatment. There was no adverse patient sequela reported. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-01848 |
| MDR Report Key | 9765347 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2016-12-05 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-02-27 |
| 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 # 2024168 |
| Manufacturer Street | 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 925914628 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABSORB |
| Generic Name | BIORESORBABLE SCAFFOLD |
| Product Code | PNY |
| Date Received | 2020-02-27 |
| Catalog Number | 1234350-23 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-02-27 |