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 2019-03-11 for ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM manufactured by Av-temecula-ct.
[138543254]
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). Date of event, implant date: estimated dates. Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated. The device was not returned for evaluation. A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided. It should be noted that the bioresorbable vascular scaffold system, absorb, instructions for use (ifu), instructs the physician to: note the product use by (expiration) date on the package. The investigation determined the reported use after expiration appears to be related to the deviation from the ifu. There is no indication of a product quality issue with respect to manufacture, design or labeling. The absorb device is currently not commercially available in the u. S; however, it is similar to a device sold in the u. S.
Patient Sequence No: 1, Text Type: N, H10
[138543257]
It was reported that from (b)(6) 2015 until (b)(6) 2016, unk absorb bio-resorbable scaffolds were implanted with expired shelf-life. There were no reported adverse patient effects. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2019-01898 |
| MDR Report Key | 8408706 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-11 |
| Date of Report | 2019-03-11 |
| Date of Event | 2015-10-01 |
| Date Mfgr Received | 2019-02-25 |
| Date Added to Maude | 2019-03-11 |
| 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 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM |
| Generic Name | BIORESORBABLE DRUG ELUTING SCAFFOLD |
| Product Code | PNY |
| Date Received | 2019-03-11 |
| 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 | 2019-03-11 |