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 2019-03-27 for ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM 1235300-18 manufactured by Av-temecula-ct.
[140118533]
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. 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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The reported patient effect of restenosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) is a known adverse event associated with the use of a coronary scaffold in native coronary arteries. Based on the case information and related record review, a conclusive cause for the reported patient effect 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.
Patient Sequence No: 1, Text Type: N, H10
[140118534]
It was reported that on (b)(6) 2017, the patient underwent a coronary stenting procedure, with implantation of a 3. 0 x 18 mm absorb gt1 scaffold in the mid left anterior descending (lad) artery. On (b)(6) 2019, coronary angiography was performed during a follow up visit. 90% stenosis was noted within the implanted scaffold area. No additional intervention was performed; however, percutaneous coronary intervention procedure is scheduled for (b)(6) 2019, with planned stent implantation. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2019-02380 |
| MDR Report Key | 8458671 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-27 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2019-04-22 |
| Device Manufacturer Date | 2016-10-01 |
| Date Added to Maude | 2019-03-27 |
| 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 | 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 | 2019-03-27 |
| Catalog Number | 1235300-18 |
| Lot Number | 6100461 |
| Device Expiration Date | 2018-04-01 |
| 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. Other; 3. Required No Informationntervention | 2019-03-27 |