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 2020-03-25 for MULTI-LINK CORONARY STENT SYSTEM 1012169-23 manufactured by Abbott Vascular.
[184901358]
The device will not be returned for evaluation, the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The other additional multi link referenced is being filed under a separate medwatch report number.
Patient Sequence No: 1, Text Type: N, H10
[184901359]
It was reported that the procedure was treat a mildly tortuous right coronary artery that was 80% stenosed. A 4. 0x18mm multi-link stent balloon was advanced to the lesion and inflated to 20 atmospheres and ruptured. During removal resistance was met with a non-abbott guiding catheter and the units had to be removed altogether. Then another 4. 0x23mm multi-link stent-balloon was advanced to the lesion and deployed without issue at 12 atmospheres. The balloon was completely deflated but when pulling it back, it was noted it did not refold tightly. During removal it got stuck in another non-abbott guiding catheter. Both devices (guiding catheter and stent-balloon) had to be removed altogether as a single unit. There was no adverse patient effects and no clinically significant delay. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[188933615]
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no other incidents. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. 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
| Report Number | 2024168-2020-02869 |
| MDR Report Key | 9879071 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2018-03-28 |
| Date Added to Maude | 2020-03-25 |
| 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 # 3005718570 (P099) |
| Manufacturer Street | CASHEL ROAD |
| Manufacturer City | CLONMEL TIPPERARY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTI-LINK CORONARY STENT SYSTEM |
| Generic Name | CORONARY STENT DELIVERY SYSTEM |
| Product Code | MAF |
| Date Received | 2020-03-25 |
| Catalog Number | 1012169-23 |
| Lot Number | 8032841 |
| 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 | 2020-03-25 |