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 2020-03-24 for ABSORB 1235250-18 manufactured by Abbott Vascular.
[187870221]
There was no reported device malfunction and the product was not returned. 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 stenosis, as listed in the absorb gt1 instructions for use (ifu), is a known adverse event associated with the use of a coronary scaffold in native coronary arteries. 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 the design, manufacture, or labeling of the device.
Patient Sequence No: 1, Text Type: N, H10
[187870222]
Patient id (b)(6). It was reported that on (b)(6) 2017, the patient underwent a coronary procedure performed to treat a lesion in the distal circumflex artery. A 2. 5 x 18 mm absorb gt1 bioresorbable vascular scaffold (bvs) was implanted. On (b)(6) 2020, a new area of stenosis, within 5 mm from the previously implanted absorb scaffold, was noted. On (b)(6) 2020, the patient was re-hospitalized and a revascularization procedure was performed, resolving the event. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2024168-2020-02828 |
MDR Report Key | 9875793 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2020-03-24 |
Date of Report | 2020-03-24 |
Date of Event | 2020-02-05 |
Date Mfgr Received | 2020-02-28 |
Device Manufacturer Date | 2016-10-04 |
Date Added to Maude | 2020-03-24 |
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 | 2020-03-24 |
Model Number | 1235250-18 |
Catalog Number | 1235250-18 |
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 | 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 | 2020-03-24 |