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 2019-02-05 for ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM manufactured by Av-temecula-ct.
[135024675]
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Unique device identifier (udi): in the absence of reported part number, udi cannot be calculated. The incident information was reviewed. 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 part and lot number was not provided. Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. The reported patient effects of myocardial infarction and restenosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use, are known adverse events associated with the use of a coronary scaffold in native coronary arteries. There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Patient Sequence No: 1, Text Type: N, H10
[135024676]
It was reported the 2. 50mm absorb stent was implanted in (b)(6) 2017. On (b)(6) 2019, the patient presented with st elevated myocardial infarction (stemi) and restenosis was noted in the absorb stent. Another stent was placed as treatment. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2019-00822 |
| MDR Report Key | 8305702 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-05 |
| Date of Event | 2019-01-13 |
| Date Mfgr Received | 2019-01-13 |
| Date Added to Maude | 2019-02-05 |
| 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 | CONNIE SPECK |
| Manufacturer Street | ABBOTT VASCULAR 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168 |
| Manufacturer Street | ABBOTT VASCULAR 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 925914628 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM |
| Generic Name | BIORESORBABLE DRUG ELUTING SCAFFOLD |
| Product Code | PNY |
| Date Received | 2019-02-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AV-TEMECULA-CT |
| Manufacturer Address | ABBOTT VASCULAR 26531 YNEZ ROAD TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2019-02-05 |